GIST Collaborative Tissue Bank

GIST PARAFFIN BLOCK TISSUE BANK

Put valuable tissue in the hands of the world’s leading researchers with one donation

Why a GIST Collaborative Tissue Bank?

Due to the rarity of GIST, one of the most urgent research needs is for tissue samples. The GIST Collaborative Tissue Bank brings together GIST researchers and GIST patients in a unique partnership. For patients, it’s an opportunity to reach the world’s leading GIST research scientists with one tissue donation, maximizing both tissue and precious research time. For researchers, it’s an opportunity to access tissue linked to GIST clinical histories and to share valuable tissue and critical data.

How is the GIST Collaborative Tissue Bank different?

The Life Raft Group (LRG), which maintains the largest patient-provided clinical database in the world, has joined with cancer researchers to create a one-of-a-kind tissue bank, where patient tissue is linked to their GIST clinical histories. The Collaborative Tissue Bank has been designed to:

· Allow multiple researchers to share rare tissue.
· Maintain patient privacy: identifying information will be removed from tissue samples and patient clinical histories.
· Create a system for researchers to share data thereby speeding up communication of vital results and reducing duplication of efforts. Stanford University (http://tma.stanford.edu) will host the shared data generated by the researchers and link to the LRG Patient Registry.

Who can participate in the GIST Collaborative Tissue Bank project?

Any GIST patient may participate in this project. If you have not previously participated in the LRG Patient Registry we will ask you to provide your clinical history and to provide ongoing medical updates. You do not need to be a formal member of the LRG to participate.

How will participants benefit?

In addition to helping to accelerate critical GIST research, patients will also reap direct benefits.

· Mutational Testing: Patient who have not had mutational testing can obtain this test free of charge through Oregon Health & Science University (OHSU). Patients may request this test through the LRG and will need to provide the name of their physician who will receive the test results directly from OHSU.
· Personal GIST History: Each participant will receive their GISTory, a timeline summarizing their GIST clinical history encompassing diagnosis, surgeries, treatments and evaluations. The history will includes information provided to us by patients including: demographics, mutational test results, CT and PET scan outcomes, dates of surgeries, medication and dosage changes, etc. The GISTory is organized in a easy-to-read format, an invaluable tool for maintaining up-to-date medical records and for sharing with the patient's healthcare team. Patients review the GISTory with the LRG staff to ensure its accuracy. Each time a medical update is received from patients, the LRG will send an updated GISTory to patients.

What am I being asked to do?

Donating Tissue takes 3 steps:

Arrange to have paraffin tissue blocks sent to LRG from the hospital(s) where you had surgery. If you have had surgery at more than one medical facility we ask that you contact all the Pathology Departments at these locations. If multiple tissue samples were taken from single tumors or from different locations during any of your surgeries (for example, primary tumor, metastasized locations or nodes), please ask that multiple samples be sent to us.

IMPORTANT NOTE: If it proves to be difficult to reach multiple facilities or obtain multiples samples, please try to get at least one sample from any surgery so that your tissue can become part of the bank. If Pathology Departments have questions or concerns, the LRG staff is available to assist.

Ask that a copy of the Pathology Report or Surgical Pathology Report associated with the blocks be included with the tissue samples.
Provide your GIST medical history through the Life Raft Group‘s Patient Registry. For those already enrolled, the LRG will provide a timeline summarizing your GIST medical history to-date. New registrants will be asked to provide their complete GIST history. All patient identification will be removed to comply with privacy laws.

How did the Collaborative Tissue Bank project develop?

Background: The LRG’s Pathway to a Cure began in 2005 to find ways to counteract the Gleevec resistance which occurs in many patients within a few years of treatment. With the traditional research and drug development process taking up to 15 years to produce new therapies, the LRG decided to take action. To accelerate the research process, the LRG forged a partnership with the research community, creating a collaborative and cooperative research effort. Our research goals were clear from the beginning: first, turn GIST from a life-threatening disease into a chronic condition managed with medication; and second, find a cure.

Research Dilemma: Due to the rarity of GIST, one of the most urgent research needs is for tissue samples. Without tissue, scientists cannot conduct basic experiments to unlock the mysteries of GIST biology and to test and find new treatments. From the beginning, the LRG recognized this need and funded both adult and pediatric tissue banks. However, even when researchers were able to acquire tissue, patient privacy regulations prevented them from having complete clinical histories of these patients and from sharing information and results with other researchers. This is complicated by the fact that patients often see multiple doctors at multiple institutions during the course of their treatment so that often no one physician or institution has a complete clinical history of that patient. Our research team came to us to see if we could find a way to overcome these research obstacles and provide them with the missing pieces of the research puzzle: GIST tissue linked to clinical histories.

The Solution: Since its inception, the LRG has been maintaining an extensive GIST patient registry which cuts across institutional and geographical boundaries by collecting information from patients. Today, with over 1000 GIST patient clinical histories, it is the largest database of its kind in the world. Working together with our research team, we devised a system to integrate this patient-based registry with our lab-based research efforts. The key is patient submission of paraffin tissue blocks. These tissue samples are on file in the pathology labs where patients had their surgeries and they remain archived by law. Tissues are typically required to be held for 5 to 6 years, but this varies by state. By having patients send their paraffin tissue blocks to LRG, who in turn will send it to the research team (without personal information to comply with research privacy regulation), researchers will have GIST tissue linked to patient clinical histories for the very first time. This unique project will allow researchers to analyze tissues in ways that have never been possible before. For example, scientists will be able to compare primary tumor tissue and metastasized tumor tissue from individual patients and then look for genetic similarities in other patients. Finally, GIST Collaborative Tissue Bank members are working to develop a shared data system so that results of this and other projects can be shared, creating a truly integrated research effort.

What is a Paraffin Tissue Block and how is this different from frozen tissue?

Both fresh frozen and paraffin tissue samples are utilized for a broad range of research studies. For this particular project, we are asking only for paraffin-based samples. Tissue samples are routinely taken during surgery for review and evaluation by pathologists. These tissues are fixed in formalin, processed to remove water, and then infused with molten paraffin wax. These tissue blocks are then filed, unless needed for research or diagnostic purposes. By law, these samples must be retained on file at the medical facility where the surgery was performed; the duration of storage is specified by state law. After the mandatory storage period samples may be destroyed and lost forever to research. Paraffin tissue blocks are relatively easy to store and ship and remain viable for research for a long period of time. Recent advancements in research technology have resulted in new and exciting methods of using paraffin tissue blocks making them an extremely valuable resource for researchers.
Paraffin block tissue is different from fresh frozen tissue samples also used by researchers. Fresh tissue samples must be frozen immediately after surgery, remain frozen during shipping and then stored in special freezers to remain viable for research purposes.

Who is studying my tissue?

The GIST Collaborative Tissue Bank members will be collaborating in a number of cross-cutting studies. They will also be conducting a variety of experiments including state-of-the-art tissue microarrays (TMA). TMAs examine the expression levels of genes or antibodies and allow comparisons of up to 500 tumor samples at one time. Other members of the research team will conduct mutational testing on the samples. All of the data generated from the studies will be shared by the entire team. For more information about individual researcher projects visit: http://www.liferaftgroup.org/research.html.

GIST Collaborative Tissue Bank members include:

Dr. Sebastian Bauer, West German Cancer Center, University of Essen, Germany
Dr. Chris Corless, Oregon Health & Science University
Dr. Maria Debiec-Rychter, The Catholic University of Leuven, Belgium
Dr. Anette Duensing, University of Pittsburgh Cancer Center
Dr. Jonathan Fletcher, Brigham & Women’s Hospital
Dr. Michael Heinrich, Oregon Health & Science University
Dr. Brian Rubin, The Cleveland Clinic
Dr. Constantine Stratakis, The National Institutes of Health, Pediatric & Wildtype Clinic
Dr. Matt Van de Rijn, Stanford University Medical Center

Donated tissue samples will reach the world’s leading GIST scientists including those listed above, making it a more efficient use of both the rare GIST tissue and precious research time. A scientific committee will also review requests by GIST scientists who are not members of the GIST Collaborative Tissue Bank to share the tissue and data. Our ultimate goal is to accelerate the speed at which lab research is conducted and the time it takes to translate these research findings into new GIST treatments.

How long will the study last?

This will be an ongoing study. There is currently no time limit and you can submit samples from new surgeries and continue to update your medical record so that researchers have access to each patient’s latest clinical progress.

Will I be able to see the research results?

Tissue microarrays will be posted on Stanford University’s TMA public website (http://tma.stanford.edu). Other analyses by the research team will be published in scientific journals and research progress reports will appear in the LRG newsletter on a regular basis. Results of experiments and tests done on anonymous tissue cannot be provided back to patients. However, as noted above, clinical mutational testing results processed through the LRG Patient Registry will be made available to patients through their physicians.

I have already donated my tissue to a research facility. Will this overlap with other studies?

Yes, but we are taking it a few steps further. The GIST Collaborative Tissue Bank is a unique collaborative and coordinated research effort, offering researchers and patients the opportunity to partner in an unprecedented way. LRG Patient Registry data matched to GIST tissue samples will allow researchers to go beyond the scope of many research studies. Additionally, sharing data through the Stanford TMA website will allow more GIST researchers to access vital and timely information benefiting all GIST research labs worldwide.

How will my personal information be protected?

The LRG will remove all personal information from patient records, pathology reports and tissue samples. Through a sophisticated data sharing and coding process, the Collaborative Tissue Bank members will be able to access and correlate the de-identified patient clinical histories and the matching tissue samples and pathology reports.

Will it cost me anything to participate in the study?

There is no cost for participating in the study. Some hospitals may charge a modest cost for processing and shipping tissue.

Where should I send my tissue samples?

You must first complete two consent forms to participate in the tissue bank.

As a part of the consent process, you will make a request for the Pathology Department to send the tissue samples and reports directly to the GIST Collaborative Tissue Bank:

GIST Collaborative Tissue Bank
c/o The Life Raft Group
155 Rt. 46W, Suite 202
Wayne, NJ 07470

For a complete tissue bank package, including consent forms, please contact the LRG at:

973-837-9092 OR
liferaft@liferaftgroup.org

Will my samples be returned?

We will honor requests by medical facilities to return the samples.

GIST Collaborative Tissue Bank Members

Dr. Sebastien Bauer - West German Cancer Center, Germany
Dr. Christopher Corless & Dr. Michael Heinrich - Oregon Health & Science Center
Dr. Marie Debiec-Rychter - The Catholic University of Leuven, Belgium
Dr. Annette Duensing - University of Pittsburgh Cancer Center
Dr. Jonathan Fletcher - Brigham & Women's Hospital
Dr. Brian Rubin - The Cleveland Clinic
Dr. Constantine Stratakis - National Institutes of Health Pediatric and Wildtype GIST Clinic
Dr. Matt van de Rijn & Dr. Rob West (Project Leaders) - Stanford University School of Medicine
The Life Raft Group - Patient Registry