IRB Number:

354-06

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer. It is being done to try to find new genes or substances that may make some people more likely to develop pancreatic conditions, and to find agents that may help to prevent, treat, or cure them.

The research staff is collecting clinical and family histories, blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer. This will help the researchers to learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. These studies will involve searching for changes in the genetic material (DNA) taken from blood and/or tissue. The information and samples will be used in current and future research studies.

Some of the future research studies could involve genetic testing. Because the genetic tests are not used for regular medical care, patients will not be told the results of the test(s). The test results will not be put in the patient's medical record either.

Who is Eligible to Participate in the Study?

1. Participant has not donated blood in the last eight weeks
2. Participant has not had surgery in the last seven days
3. Participant has not had a blood transfusion in the last seven days
4. Participant is past his/her 18th birthday
5. Participant is mentally competent and able to provide informed consent
6. Participant is able to understand and read English

(At least ONE must be checked to be eligible)

_____ Has a known or suspected pancreatic mass, islet cell tumor, IPMN (Intraductal papillary mucinous neoplasms), hereditary pancreatitis

_____ Diagnosed with proven or suspected cancer of the pancreas

What is Involved With this Study?

1. Patients will be given two surveys to fill out. One will ask about their health and family history of pancreatic conditions (including cancer) and one will be asking about food preparation and intake. Both may be completed and mailed back to the research staff at the patient's convenience. The surveys will take about an hour each to complete. The data from these surveys may be used in future research studies.

2. Patients will be asked to sign a medical release allowing the research staff to review the patient's medical record and/or request a small piece of any leftover tissue they may have had taken from a previous surgery to be used for future research studies.

3. The research staff will ask to collect a blood sample for future research studies.

4. The research staff may ask to collect a sample of cells from the patient's mouth by mouthwash, for future research studies.

5. Patients will be asked to complete a follow up survey which asks questions about their health, health practices, and family history, approximately six months and one year after the patient enrolls in the study. This survey will take about 15-30 minutes to complete.

6. If the patient indicates a family history of pancreatic disease, the research staff may ask the patient to provide names and addresses of relatives of interest so that the researchers may approach those relatives for participation in this study.

7. If the patient meets certain criteria, the research staff may ask to collect a stool sample for research studies

How long will the Study run?

Participation in this data and tissue registry will last approximately one year, however, the patient's data and samples will be stored indefinitely. No additional visits to Mayo Clinic are necessary for participation in this data and tissue registry.

Sponsor(s): National Institutes of Health (NIH)

Study Activation/Registration Date: 10/01/2000

IRB Review and Approval Date: 03/14/2008

Study Type: Tissue and Data Registry

Projected Accrual: The plan is to have up to 5,000 patients participate from multiple medical centers.

Costs of Study:Patients will not need to pay for any procedures which are done just for this research study. They will not be charged extra for the collection of blood, buccal (cheek) cells, or stool. If the patient does incur any expenses related to the collection of blood, buccal (cheek) cells, or stool; they will be reimbursed for those expenses. The only other procedures that this study involves are collection of any tissue specimens, which are being done as part of the patient?s health evaluation. The patient and/or their health plan will pay for all other tests and procedures that they would normally have as part of their regular medical care.

Principal Investigator: Gloria M. Petersen, PhD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 10/02/2009