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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Mayo Clinic
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gloria M. Petersen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00830557
First received: January 27, 2009
Last updated: September 12, 2016
Last verified: September 2016
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: medical chart review
    baseline, 12 month and 36 months
    Other: survey administration
    baseline, 6 month, 12 month
    Other: biospecimen collection
    baseline
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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pancreas disease patients
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830557

Contacts
Contact: Sarah Amundson 1-800-914-7962 pancreas@mayo.edu
Contact: Bridget Eversman 1-800-914-7962 pancreas@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gloria M. Petersen, PhD, FACMG Mayo Clinic
  More Information

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: September 12, 2016
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 Neoplasms
Pancreatic Diseases
Adenoma, Islet Cell
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on December 08, 2016