July 2008

Q: WHO WILL HAVE ACCESS TO THE SPECIMEN?

A: The Biospecimen Resource will permit the study of cases entered on RTOG clinical trials by any qualified investigator making an application to the group or to the resource via an Intergroup. The RTOG Translational Research Committee, which decides whether specimens can be allocated for the project proposed, reviews all applications. The investigator must have NCI or other funds available to carry out the research project. Procedures and policies governing this access conform to the Intergroup Tissue Bank guidelines. Applications are available on the RTOG web site, which can be accessed at www.rtog.org.

Q: WHAT KINDS OF TESTING WILL BE DONE ON THE SPECIMENS?

A: Researchers are interested to see how normal cells become cancer cells, how our bodies react to those cancer cells, how cancer cells spread in the body, and how cancer cells respond to treatment. In order to find answers to those questions, standardized laboratory tests are performed by qualified investigators who have funding from NCI or other agencies to conduct testing on cancer specimens. Specific aspects of the tests to be done are included in the research protocol the patient is registered to and/or is explained in the patient consent form. Those tests may include immunohistochemistry, in-situ hybridization, flow cytometry, and a variety of molecular tests.

Q: WHAT IS GENETIC RESEARCH?

A: Some human diseases are caused by a defective gene. An example is cystic fibrosis, a disease of the mucous glands throughout the body that usually develops during childhood and makes breathing increasingly difficult. If a child receives two copies of the defective gene (called the CF gene), one copy from each parent, the child will develop the disease. To help you understand the nature of genetic research, we suggest you visit the following websites on the Internet:

• http://www.accessexcellence.org/AE/AEPC/NIH/index.htm "Understanding Gene Testing", which contains general information about the methods and reasons for gene testing.
• http://rex.nci.nih.gov/behindthenews/ugt/ugtframe.htm"Understanding Gene Testing", another website, provided by the National Cancer Institute, that explains gene testing.
• http://www.genome.gov/glossary.cfm "Glossary of Genetic Terms", which has written descriptions of terms, illustrations and also audio descriptions recorded by experts that provide additional details that you may find very useful.

Q: WILL GENETIC TESTING BE DONE ON SUBMITTED SPECIMENS

A: Genetic research on cancer specimens involves the discovery of genes that are involved in the process of cancer transformation. Thus, many studies commonly performed (such as p53 mutational status or detection of increased levels of the Her-2 gene) fit into the category of "genetic" research. This type of research does not allow DNA-typing of the person from whom the specimen was removed because of the extensive processing of the specimen that occurred before the Biospecimen Resource received it. DNA-typing can be performed on blood samples received from patients; however, this testing would never be done without the express permission of the patient. There is very little risk of disclosure of such information to other parties such as insurance companies, since the Biospecimen Resource does not have access to clinical or demographic information on patients and also does not have access to researcher-derived genetic information. Any research involving the discovery of specific genes requires a specific protocol and specific patient consent.

Q: WHERE ARE THE SPECIMENS STORED?

A: The RTOG Biospecimen Resource is located at University of California San Francisco, 1657 Scott St, Room 223, San Francisco, CA 94115. UCSF is accredited by the College of American Pathologists (CAP) and The Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The Biospecimen Resource is located in a secure building at the UCSF Mt Zion Campus with access limited to Biospecimen Resource personnel. The specimens are stored in a cool, dry environment using normal specimen storing techniques.

Q: HOW ARE THE SPECIMENS LABELED ONCE IT IS RECEIVED?

A: Upon receipt, the specimen are labeled with the study and case numbers only. These numbers then will continue to be the only identifiers associated with the specimen.

Q: IS THERE ANY CLINICAL INFORMATION IN THE DATABASE THAT CAN BE LINKED TO THE PATIENT?

A: The information kept in the Biospecimen Resource database includes: the number of specimens received, the date the specimens were received, if any material has been sent to a qualifying investigator, who that investigator is, what type of material was sent, and when it was sent. No clinical information, demographic, or other identifying information is kept in the database. Cases are only identified by the study and case numbers. The database also does not contain any laboratory correlative study results for any patient.

Q: WHAT TYPES OF SECURITY MEASURES ARE IN PLACE TO PROTECT UNAUTHORIZED USERS FROM ACCESSING THE DATABASE?

A: The database is kept on a server within the UCSF Medical Center's firewall. All appropriate physical and network security precautions have been taken. The database is kept only on that computer's hard drive and is not available from the hospital network. The database is backed up daily onto magnetic tape and the backups are stored in a secure offsite location. The only authorized users are the Biospecimen Resource manager, RTOG Biospecimen Resource lab workers and the Biospecimen Resource director. Both the manager and director have signed agreements to maintain confidentiality of samples within the Biospecimen Resource. They also have completed an Office of Human Subjects Research (OHSR) training course on the protection of human subjects.

Q: SINCE SPECIMENS ARE STORED ANONYMOUSLY, HOW CAN PATIENTS ASK THAT THEIR SPECIMENS BE RETURNED OR DESTROYED?

A: Patients should contact the institution that enrolled them on the clinical trial. The institution will supply the study and case numbers, which will allow retrieval of the specimens.

Q: WHAT SAMPLES ARE SENT TO THE BIOSPECIMEN RESOURCE?

A: At the time of the patient's surgery or biopsy, when tumor/tissue is removed, tissue is sent to the institution's pathology department for routine testing and diagnosis. After that process is completed, the remaining tumor samples are stored in the pathology department. The patient is being asked for permission to use the remainder of the tumor samples for additional research. Since this tissue is removed at the time of surgery or biopsy, the permission to use this tissue will not lead to any additional procedures or expense. In addition, in some clinical trials, patients are asked to submit serum (blood) samples, which are frozen and stored at the Biospecimen Resource. Upon receipt, the serum samples are labeled with the study and case numbers only. These numbers then will continue to be the only identifiers associated with these specimens.

Q: HOW LONG WILL THE BIOSPECIMEN BE STORED?

A: The RTOG Bospecimen Resource is supported by the National Cancer Institute to collect, store, and distribute these specimens. The specimens will be stored for an indefinite period of time. If at anytime the patient withdraws consent to store and use their specimens, they will be returned to the institution that submitted them, provided any specimen are left in storage. The specimen also will be returned within 24 hours if needed for patient, physician, or legal reasons. These requests should be sent in writing to the Biospecimen Resource Manager at UCSF, or by faxing the request to 415-476-5271.

Q: UNDER WHAT CONDITIONS WILL DATA BE RELEASED FROM THE BIOSPECIMEN RESOURCE?

A: The only data released from the Biospecimen Resource is the number of specimens available for aggregated cases on each clinical trial. No case specific information is released except to the RTOG central office, where all other information about each patient is stored and maintained. RTOG maintains specific security measures approved by the National Cancer Institute for protection of patient-specific information. There is never a name or any other identifier given with this information and no clinical information is available for release.

Q: WILL THE PATIENT BENEFIT FROM THE USE OF THEIR SPECIMEN?

A: The patient will NOT experience a medical benefit from this research. The biospecimen resources allow research to be performed on clinically standardized patient populations that may give us important information about prognostic factors, treatment selection factors, and biologic behavior. Cancer patients in general may benefit because the results of research may change treatment for cancer patients in the future.

Q: WHAT KINDS OF TESTING WILL BE DONE ON THE SPECIMENS IN THE FUTURE?

A: In the years to come, there may be development of new technology that will help us to learn more about cancer. Therefore, specimens are retained for future unspecified projects. As part of the consent process, patients can agree whether they would permit such use or whether they would like to be contacted before such use occurs; as of May 15, 2001, this consent information is retained in the Biospecimen Resource. When a new technology or test is performed, only those cases having appropriate permission will be utilized.

Q: WILL THIS RESEARCH FIND OUT PERSONAL INFORMATION ABOUT MEMBERS OF THE PATIENT'S FAMILY?

A: No.

Q: WILL THIS RESEARCH RESULT IN THE DEVELOPMENT OF A COMMERCIAL PRODUCT?

A: The research may lead to pharmaceutical development of new products. This is a possibility, but all possible methods and measures will be used in order to protect the privacy and confidentiality of the patient.

Q: HOW IS PATIENTS' PARTICIPATION IN THE STUDY AFFECTED IF THEY DECIDE NOT TO PARTICIPATE IN THE SPECIMEN BANKING PORTION OF THE STUDY?

A: Deciding whether to take part in the specimen banking portion of the clinical trial is the patient's choice. If patients decide not to participate, it will not affect the medical care they receive. They may participate in the treatment part of most RTOG studies without agreeing to let the RTOG Biospecimen Resource store their specimen indefinitely. However, there are clinical trials that require specimen submission for testing and/or banking of the specimen - clinical studies in which submission of specimen is very important to the scientific research being done. In these cases, required specimen submission is clearly stated in the protocol and in consent forms. A patient would not be able to participate in the study unless the patient consented to have specimen submitted for the purposes described in the study.