BostonGene Subject Information and Informed Consent Form

Protocol Title
BEGIN (BostonGene and Exigent Genomic INsight) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting
Protocol #
BGER001
Sponsor
BostonGene Corporation
Principal Investigator
Nathan Fowler, MD
Institution
BostonGene Corporation
Address
95 Sawyer Road, Waltham, MA 02453
Telephone
(781) 467-6870

Key Information Statement

The purpose of this study is to demonstrate the feasibility and benefit of comprehensive molecular testing in advanced cancer patients. Study subjects will provide relevant clinical and genetic information and a tissue sample for molecular testing. There are no study visits. Participation is completely voluntary. While all of your information is stored in a highly-secured HIPAA-compliant environment, there is the risk of loss of confidentiality of your medical and personal information collected for this study.


If you are interested in learning more about this study, please continue to read below, where you will find additional information related to this study such as the risks, benefits, procedures, alternatives, and contact information.

Key Information about This Research Study

You are being asked to be a subject in a research study because molecular testing of your tumor is being considered to help guide your treatment. Molecular testing is performed to identify “actionable” findings in your tumor that can help determine which therapies may be more effective to treat the tumor.


The following table is a concise and focused presentation of key information to assist you in understanding why you might or might not want to participate in the research.

Purpose
This is a research study to determine the feasibility and clinical usefulness of a tumor molecular test, the BostonGene Tumor Portrait™ test.
Experimental/ Investigational
You will not receive any experimental drugs or procedures as part of this study. Molecular testing is considered part of routine cancer care.
Voluntary Participation
Your decision to be in this study is voluntary.
Withdrawal
If you decide to be in this study and then change your mind, you can leave the study at any time without penalty.
Length of Participation
Your active participation in this study will be over after you have completed the molecular testing; however, the study team will continue to follow the types of treatments you receive, as well as the long-term outcomes of those treatments for up to 2 years.
Procedures
This is an observational study. You will receive the results of any tests that are considered standard of care and your doctors may use this information for choosing your treatments. You will not receive the results of any research tests.

The study doctor will explain which procedures are being done for research, and which will be done as part of your standard care even if you don’t participate.
Risks
There are not expected to be any physical risks to you as part of this study.
Benefit
You will receive the results of any tests that are considered standard of care and your doctors may use this information for choosing your treatments. You will not receive the results of any research tests. There may be no benefits for you in this study. Future patients may benefit from what is learned.
Alternatives to Study Participation
Your alternatives include not participating and having standard of care testing done outside of this research.
Costs
Molecular testing is considered part of routine cancer care, so testing will be billed to you and/or your insurance provider. If your doctor decides you need to have a biopsy performed to collect tissue for this testing, this will be done as part of your routine care and will also be charged to you and/or your insurance provider.
Confidentiality
There are provisions in place by the study protocol and study site to help protect the privacy and confidentiality of your personal health information and study information.
This overview does not include all of the information you need to know before deciding whether or not to take part. Much additional detail is given in the full consent document, which can be found on the pages that follow. Be sure to review the rest of this consent form before deciding about participation.

Informed Consent Form

This consent form explains the research study. Before you decide to be a part of this study, you need to know why the research is being done, what it will involve and the risks and benefits. Ask the study doctor and study staff to explain anything in this form or if you want more information. Please take time to read this form carefully. Feel free to discuss it with your relatives, friends and your primary care physician. If you agree to take part in this research study, you must sign this consent form.


Disclosure of Financial Interests
BostonGene, the sponsor of this study, is providing funds for conducting this research study. The Principal Investigator for this study, Nathan Fowler, MD, and all members of the study team are employees of BostonGene. Contribution of your information for this study could lead to future research that may result in financial gain for the company. Participants, such as yourself, will not benefit financially from this study or any future research conducted with your information. If you would like more information about this matter, please ask the study team and they will assist you.
Purpose of the Study
You are being asked to be a subject in a research study because molecular testing of your tumor is being considered to help guide your treatment. Molecular testing is performed to identify “actionable” findings in your tumor that can help determine which therapies may be more effective to treat the tumor. Researchers want to learn more about the usefulness of different tumor testing methods in guiding your cancer care. The purpose of this study is to determine the feasibility and clinical usefulness of one tumor molecular test, the BostonGene Tumor Portrait™ test.
Number of Subjects and Length of Study Participation
About 400 subjects are expected to participate in this study at multiple research sites in the United States. Your active participation in this study will be over after you have completed the molecular testing; however, the study team will continue to follow the types of treatments you receive, as well as the long-term outcomes and adverse events of those treatments for up to 2 years.
Study Procedures
If you agree to participate in this study, you will be asked to sign this consent form. You will be enrolled in 1 of 4 groups depending on the type of disease you have. If you have breast cancer, you will be in Group 1. If you have non-small cell lung cancer (NSCLC), you will be in Group 2. If you have melanoma, you will be in Group 3. If you have sarcoma, you will be in Group 4. Participants in all groups will have tumor molecular testing by BostonGene’s Tumor Portrait™ test.

Tissue Collection: The BostonGene Tumor Portrait™ test will use a sample of your tumor tissue. For all groups, either previously collected (archival) tumor tissue from a previously performed procedure or a new biopsy will be used for tumor molecular testing. The study doctor will tell you what type of biopsy you will have.

Liquid Biopsy for Molecular Testing: Participants may also have a liquid biopsy performed for tumor molecular testing in addition to a tumor biopsy. A liquid biopsy uses plasma and cells (from a blood draw) for molecular testing. We will draw at least one tube of blood as part of your tumor testing and 2 additional tubes of blood for the liquid biopsy.

Genetic Research: Your genes are in the cells in your body. Genes make you different from anyone else. Some genes are responsible for inherited traits like hair and eye color. Some genes affect the chances that a person will get a certain disease or how their body responds to drugs. Research samples collected from you as part of this study will be used for genetic research, which may include whole genome sequencing. Whole genome sequencing is a type of testing in which researchers study your entire genetic makeup (DNA). This may help researchers learn how changes in the ordering of genes may affect a disease or response to treatment. No tests other than those described in this form will be performed on your sample without your permission. To help protect your privacy, your sample will be identified by your subject number, not your name. Only the study doctor and other authorized persons will be able to link your subject number with your name. Samples and data collected during this study may be shared with researchers for the purposes of the study.
Subject Responsibilities
If you take part in this research, you will be asked to provide clinical information to the study team and your tumor tissue from a previously collected biopsy or a new biopsy will be collected.
Risks and Discomforts
Through your participation in this study, you may learn information about your genetic risk for cancer and/or other non-cancer diseases. There are many types of genetic tests that can be done, and the genetic testing that may be done through this research study cannot find all types of hereditary (inherited) risks. Standard research testing may not be as accurate as genetic testing performed in CLIA-certified laboratories. A CLIA-certified lab is a lab that is authorized to release results from patient tests for clinical and diagnostic purposes. For this reason, participation in this research study is not a replacement for genetic counseling and clinical genetic testing, if your doctor thinks it is needed. If you are concerned about any genetic risks because of your personal and family history, you should discuss this concern with your treating doctor and health care team so that you can be referred for risk assessment, genetic counseling, and/or consideration for clinical genetic testing to address your specific concern.

Testing through BostonGene is being done for your routine cancer care. The results of these tests will be entered into your medical record and will be used to help guide your therapy.

Any research testing done in the research laboratory will NOT be entered into your permanent medical record and will not be made available to you. However, your treating doctor will have access to these test results, and if they think these results are important to your care, they can order additional tests in a clinical laboratory to confirm the test results. Your doctors at other institutions will not have access to the results of this research testing, unless your treating doctor has first confirmed the research results in the clinical laboratory.

Genetic Research Risks: The sponsor has taken steps to safeguard your genetic testing information, so the risk of loss of confidentiality is small, however, if confidentiality is broken, results of genetic testing may become available to insurance carriers or employers. The knowledge of this information has the potential to lead to discrimination in employment or insurance. Someone with a known genetic condition indicating a susceptibility to develop a disease or condition might be denied a job or a promotion, or denied health or life insurance, because they are regarded as a health risks and therefore an economic risk. Carriers for a genetic disorder might be discriminated against and viewed as having the potential to have a child with a genetic condition.

There is a federal law called the Genetic Information Nondiscrimination Act (GINA) that, in general, makes it illegal for health insurance companies, group health plans, and most employers (except those with fewer than 15 employees) to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

The process of DNA and RNA sequencing is not 100% error free. The analysis of nucleic acids by next-generation sequencing (NGS) can be affected by multiple factors and may be influenced by specimen collection and storage processes. The lack of detection of a genomic alteration does not definitively rule out that the patient does not carry this genomic variation. Detection of an alteration does not necessarily indicate pharmacologic effectiveness (or lack thereof) of any therapeutic or therapeutic regimen.

There are no risks of physical injury associated with your participation in this study. However, having tissue biopsies performed as a part of SOC tumor molecular testing may cause pain, bruising, bleeding, redness, low blood pressure, swelling, and/or infection at the site of the biopsies. An allergic reaction to the anesthetic may occur. A scar may form at the biopsy site. You may sign a separate consent form for the biopsy that describes the risks in more detail. Having blood draws for liquid biopsy or as part of your tumor test may cause pain, bruising, light-headedness, and rarely, infection at the site of the biopsies.
New Information
You will be notified in a timely way if important new findings become known that may affect your willingness to continue in the study.

Clinically Relevant Research Results
You will receive the results of any tests that are considered standard of care and your doctors may use this information for choosing your treatments. The overall results of this study may or may not be available to you at the end of the study. The study doctor will also explain if and when you will receive individual research results that may have clinical significance.
Benefits
There is no guarantee that your condition will improve as a result of your participation in this study. It may stay the same or worsen. However, the information learned from this study may help other people with this disease in the future.
Alternatives to Study Participation
Your alternatives include not participating and having standard of care testing done outside of this research.
Costs of Participation
Certain tests, procedures, and/or drugs that you may receive as part of this study may be without cost to you because they are for research purposes only. However, your insurance provider and/or you may be financially responsible for the cost of care and treatment of any complications resulting from the research tests, procedures, and/or drugs. Standard medical care that you receive under this research study will be billed to your insurance provider and/or you in the ordinary manner. Before taking part in this study, you may ask about which parts of the research-related care may be provided without charge, which costs your insurance provider may pay for, and which costs may be your responsibility. You may ask that a financial counselor be made available to you to talk about the costs of this study.
Reimbursement
You will not receive any compensation for participating in the study. Your biospecimens may be used for commercial profit and you will not share in this profit. Samples that are collected from you in this study may be used for the development of treatments, devices, new drugs, or patentable procedures that may result in commercial profit. There are no plans to compensate you for any patents or discoveries that may result from your participation in this research.
Compensation for Injury
For medical emergencies, call 911. If you become ill or are hurt while you are in this study, contact your study doctor immediately. The study doctor will assist you in obtaining appropriate medical treatment. The institution will not be responsible for the costs of treatment caused by the properly performed study procedures.

The sponsor will pay for reasonable and necessary medical treatment of injuries and illness that are a direct result of study procedures that are required by the study protocol and that were done correctly and only because you were in this study.

The sponsor will not cover the costs of your study-related injury or illness if:
· The sponsor and/or the study doctor do not think the condition or injury is a direct result of your being in the study;
· The injury is attributable to the underlying disease or a pre-existing medical condition or the natural progression of an underlying disease or was deliberately caused;
· You do not follow the instructions of the study plan.

No other compensation will be offered by the sponsor, including for things such as lost wages or discomfort. You are not waiving any legal right to seek additional compensation through the courts by signing this form.
Confidentiality
To the extent allowed by law, every effort will be made to keep your personal information confidential. Information from this study will be submitted to the study sponsor and to the U.S. Food and Drug Administration (FDA). It may be submitted to governmental agencies in other countries where the study product may be considered for approval. Medical records, which identify you and the consent form signed by you, will be looked at by the sponsor or the sponsor’s representatives and may be looked at by the FDA and other regulatory agencies, and the Institutional Review Board. While these parties are aware of the need to keep your information confidential, total confidentiality cannot be guaranteed. The results of this research project may be presented at meetings or in publications; however, you will not be identified in these presentations and/ or publications.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Authorization to use and disclose protected health information (PHI)
Federal regulations give you certain rights related to your health information. These include the right to know who will be able to get the information and why they may be able to get it. The study doctor must get your authorization (permission) to use or give out any health information that might identify you. If you choose to be in this study, the study doctor will get personal information about you. This may include information that might identify you. The results of this research may also be able to be linked to you. The same level of data protection that covers your individual data does not apply to summary results (when data from the whole study is combined). The study doctor may also get information about your health, including:
· Past and present medical records
· Research records
· Records about phone calls made as part of this research
· Records about your study visits
· Information obtained during this research about laboratory test results
· Results from diagnostic and medical procedures including but not limited to X-rays, physical examinations and medical history
· Billing records

Information about your health may be used and given to others by the study doctor and staff. They might see the research information during and after the study. Your information may be given to the sponsor of this research. “Sponsor” includes any persons or companies that are working for or with the sponsor, or are owned by the sponsor. They may also view additional PHI in study records during the monitoring process. Information about you and your health which might identify you may be given to:
· The U.S. Food and Drug Administration
· Department of Health and Human Services agencies
· Governmental agencies in other countries
· The Institutional Review Board
· Accrediting agencies
· Data safety monitoring boards
· Health insurers and payers
· Other individuals and organizations that analyze or use your information in connection with these research activities, including laboratories, contract research organization and study sites (if you transfer to another study site)

Your personal health information may be further shared by the groups above. If shared by them, the information will no longer be covered by the U.S. federal privacy laws. However, these groups are committed to keeping your personal health information confidential. If you give permission to give your identifiable health information to a person or business, the information may no longer be protected. There is a risk that your information will be released to others without your permission.

Information about you and your health that might identify you may be given to others to carry out the research study. The sponsor will analyze and evaluate the results of the study. In addition, people from the sponsor and its consultants will be visiting the research site. They will follow how the study is done, and they will be reviewing your information for this purpose. The information may be given to the FDA. In some situations, the FDA could be required to reveal the names of participants. It may also be given to governmental agencies in other countries. This is done so the sponsor can receive marketing approval for new products resulting from this research. The information may also be used to meet the reporting requirements of governmental agencies. The results of this research may be published in scientific journals or presented at medical meetings, but your identity will not be disclosed.

The Sponsor and others can learn about cancer and other diseases from your banked samples and data. In the future, people who may do research with these samples and data may need to know more information about your health. This information may be collected from your medical record. The Sponsor will make reasonable efforts to preserve your privacy, but cannot guarantee complete privacy. Sometimes your samples and data may be used for genetic research about diseases that are passed on in families. Genetic research may result in the development of beneficial treatments, devices, new drugs, or patentable procedures. If this happens, there are no plans to compensate you. The Sponsor will not be able to give you, your family, or your doctor the reports about the research done with these samples and data. Identifiers may be removed from your samples or data where retention of personal identifiers is not necessary for research or where such removal is necessary for de-identified research purposes, including future research related to cancer diagnosis, testing, and therapies in accordance with applicable law.

If you withdraw your consent to the storage of leftover samples in the tissue bank, then they will no longer be collected for storage. Any of your samples that remain in the tissue bank will no longer be used for research and will be destroyed.

However, if any of your de-identified samples or data were already released for research purposes before you withdrew consent, the Sponsor will not be able to destroy them.

This authorization does not have an expiration date. If you do not withdraw this authorization in writing, it will remain in effect indefinitely. The permission to use your PHI will continue indefinitely unless you withdraw your authorization in writing. If you withdraw your authorization, you will be removed from the study and the data collected about you up to that point can be used and included in data analysis. However, no further information about you will be collected.

By signing this consent form, you are giving permission to use and give out the health information listed above for the purposes described above. You do not have to sign this consent form. If you choose not to sign this consent form, you will not be able to be in this research study. Your decision not to sign this consent form will not have any effect on your medical care and you will not lose any benefits or legal rights to which you are entitled. You have the right to review and copy your health information. However, if you decide to be in this study and sign this permission form, you may not be allowed to look at or copy your information until after the research is completed.

You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor at the address on the front of this informed consent form. If you withdraw your permission, you will not be able to continue being in this study, but you will not have any penalty or loss of access to treatment or other benefits to which you are entitled. When you withdraw your permission, no new health information which might identify you will be gathered after that date. Information that has already been gathered may still be used and given to others. This would be done if it were necessary for the research to be reliable.

Collection of Identifiable Private Information or Identifiable Biospecimens:
Identifiers might be removed from your identifiable private information or identifiable biospecimens. After such removal, the information or biospecimens could be used for future research studies, distributed to another investigator for future research studies without your additional informed consent (or consent from your legally authorized representative), or used in scientific, medical, or marketing publications. If all identifying information is removed, you will not be asked for additional permission before future research is performed.

The Sponsor may also contact you regarding ongoing research, including findings specific to your disease or genomic data, as well as to obtain information regarding your future medical care. By signing below, you agree to allow the Sponsor to contact you about future research opportunities. You may also receive information beneficial to you or your family, although you may also receive information regarding your or your family’s risk for certain diseases and conditions. The Sponsor will provide such secondary findings because they may describe your or your family’s risk for certain cancers and may be beneficial for you and your family. It is strongly recommended that you receive additional consultation from your doctor or a genetic counselor regarding any secondary results you receive that are unrelated to the reason for the testing. For a list of medical geneticists and counselors who may be available in your area, please visit the National Society of Genetic Counselors website at nsgc.org.

Notice Concerning HIV-Related Information: HIV-related information that either is collected as part of the research or that may already exist in your medical record might be accessed for the research by the research staff and the study sponsor, but will not be shared with others without your authorization, unless federal or state law requires the disclosure. You have a right to request a list of people who may receive or use your HIV-related information without authorization. If you experience discrimination because of the release or disclosure of HIV-related information, you may contact the agencies responsible for protecting your rights.
Voluntary Participation and Withdrawal
Your participation in this study is voluntary. You may decide not to participate or you may stop your participation at any time, without penalty or loss of benefits or medical care to which you are otherwise entitled. If you decide to leave the study, please tell the study doctor. Upon your withdrawal, no additional data will be collected from you. However, any data collected prior to your withdrawal may still be used for research purposes. It is also possible that the data may have already been used for research purposes and the data derived from such research will not be destroyed.

Your participation in this study may be stopped without your consent at any time and for any reason by the study doctor, the sponsor, the FDA and other regulatory authorities. Reasons you may be withdrawn from the study include it is determined to be in your best interest, you do not follow the study instructions, the study is stopped, or for other administrative reasons. If you leave the study early, you may be asked to return to the study doctor’s office for a final study visit for your safety.
Contacts for Questions, Complaints, Concerns
If you have any questions or requests for information relating to this research study or your participation in it, or if you want to voice a complaint or concern about this research, or if you have a study related injury, you may contact Dr. Nathan Fowler at 781-467-6870. Signing this consent and authorization form is optional but you cannot take part in this study or receive study-related treatment if you do not agree and sign.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

STATEMENT OF CONSENT - SIGNATURES

By signing this form, I confirm the following:


  • I have read all of this consent form.
  • All of my questions have been answered to my satisfaction.
  • I can leave the study at any time without giving a reason and without penalty.
  • I agree to the collection, use, sharing and analysis of my personal health information and study information collected as part of this study by the sponsor and other authorized persons and regulatory agencies as described in this form.
  • I will be given a copy of this signed and dated consent form to keep.
  • I do not give up any legal rights that I would otherwise have if I were not in this study.

I voluntarily agree to participate in this study.

BostonGene Subject Information and Informed Consent Form

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