Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
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Purpose
RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future.
PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.
| Condition | Intervention |
|---|---|
|
Islet Cell Tumor Pancreatic Cancer Pancreatic Disease |
Other: medical chart review Other: survey administration Other: biospecimen collection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Biospecimen Resource for Pancreas Research, a Data & Tissue Bank (Also Known as a Bio-repository, Bio-bank, Data & Tissue Database, Data & Tissue Registry, Etc.) to Help Advance Research in Pancreas Disease |
- Collection of clinical data, health and family histories by survey [ Time Frame: baseline enrollment, 6 months, 12 months ] [ Designated as safety issue: No ]
- Collection of blood and/or tissue, fecal and oral specimens [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Collection of information regarding food preparation and intake by survey [ Time Frame: baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Two 10mL plasma tubes, two 10mL serum tubes and one 10mL heparin tube collected. DNA extracted from lymphocytes. Possible saliva collection for DNA extraction. Waste tissue from prior surgery may be collected. Stool samples may be collected.
| Estimated Enrollment: | 7500 |
| Study Start Date: | October 2000 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
-
Other: medical chart review
OBJECTIVES:
Primary
- To collect clinical data and family histories and blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer, for use in future studies.
- To collect information regarding food preparation and intake in these patients.
Secondary
- To make available to researchers medical data and biospecimens to enable them to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer.
- To investigate genes or substances that increase susceptibility of developing pancreatic conditions.
- To find agents that may help prevent, treat, or cure these conditions.
- To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
OUTLINE: This is a multicenter study.
Patients complete two 1-hour surveys assessing health, clinical and family history of pancreatic conditions including cancer, and food preparation and intake. Patients also complete a 15- to 30-minute follow up survey at 6 months and 1 year to assess health, health practices, and family history. A review of the patient's medical information is obtained from the medical record.
Blood samples are collected for future research studies. Oral cells and stool samples may also be collected for future studies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pancreas disease patients
DISEASE CHARACTERISTICS:
Diagnosis or suspicion of at least one of the following:
- Pancreatic cancer
- Pancreatic mass
- Islet cell tumor
- Intraductal papillary mucinous neoplasms (IPMN)
- Hereditary pancreatitis
PATIENT CHARACTERISTICS:
- Able to understand and read English
- Mentally competent and able to provide informed consent
- Has not donated blood within the past 8 weeks
PRIOR CONCURRENT THERAPY:
- At least 7 days since prior blood transfusion
- At least 7 days since prior surgery
Contacts and Locations| Contact: Bridget Eversman | 1-800-914-7962 | pancreas@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Principal Investigator: | Gloria M. Petersen, PhD, FACMG | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gloria M. Petersen, PhD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00830557 History of Changes |
| Other Study ID Numbers: | 354-06, P50CA102701-08, CDR0000613100 |
| Study First Received: | January 27, 2009 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
recurrent pancreatic cancer stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
recurrent islet cell carcinoma pancreatic alpha cell carcinoma pancreatic beta islet cell carcinoma pancreatic delta cell carcinoma pancreatic G-cell carcinoma |
Additional relevant MeSH terms:
|
Pancreatic Diseases Pancreatic Neoplasms Adenoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Neoplasms by Site |
Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013