Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT00830557
Collaborator
National Cancer Institute (NCI) (NIH)
7,500
1
263
28.5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: medical chart review
  • Other: survey administration
  • Other: biospecimen collection

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
7500 participants
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
Study Start Date :
Oct 1, 2000
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Collection of clinical data, health and family histories by survey [baseline enrollment, 6 months, 12 months]

  2. Collection of blood and/or tissue, fecal and oral specimens [baseline]

  3. Collection of information regarding food preparation and intake by survey [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mayo Clinic Cancer Center Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gloria M. Petersen, PhD, FACMG, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gloria M. Petersen, PhD, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00830557
Other Study ID Numbers:
  • 354-06
  • P50CA102701-08
  • CDR0000613100
First Posted:
Jan 28, 2009
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021

Study Results

No Results Posted as of Sep 29, 2021