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

This study is currently recruiting participants.
Verified January 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gloria M. Petersen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00830557
First received: January 27, 2009
Last updated: January 24, 2014
Last verified: January 2014

January 27, 2009
January 24, 2014
October 2000
January 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Collection of clinical data, health and family histories by survey [ Designated as safety issue: No ]
  • Collection of blood and/or tissue, fecal and oral specimens [ Designated as safety issue: No ]
  • Collection of information regarding food preparation and intake by survey [ Designated as safety issue: No ]
  • Establish a medical information and biospecimen bank for future research studies [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00830557 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

Pancreas disease patients

  • Islet Cell Tumor
  • Pancreatic Cancer
  • Pancreatic Disease
  • Other: medical chart review
    baseline, 12 month and 36 months
  • Other: survey administration
    baseline, 6 month, 12 month
  • Other: biospecimen collection
    baseline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7500
August 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bridget Eversman 1-800-914-7962 pancreas@mayo.edu
Contact: Sarah Amundson 1-800-914-7962 pancreas@mayo.edu
United States
 
NCT00830557
354-06, P50CA102701-08, CDR0000613100
Yes
Gloria M. Petersen, Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Gloria M. Petersen, PhD, FACMG Mayo Clinic
Mayo Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP