Text Size

Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gloria M. Petersen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00835133
First received: January 31, 2009
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.


Condition Intervention
Familial Pancreatic Cancer
 Other: biologic sample preservation procedure
Other: medical chart review
Other: survey administration

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Biospecimen Resource for Familial Pancreas Research, a Data and Tissue Registry (Also Known as a Bio-repository, Bio-bank, Data and Tissue Database, Data and Tissue Bank, Etc.) to Help Advance Research in Familial Pancreas Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Collection of familial data and biospecimens in a data and tissue repository for familial pancreas research [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Two 10mL plasma tubes and two 10mL serum tubes collected. DNA extracted from blood lymphocytes. Possible saliva sample for DNA extraction. Waste tissue from previous surgery may be requested.


Estimated Enrollment: 4000
Study Start Date: August 2002
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: biologic sample preservation procedure
    one blood sample or saliva sample collection
    Other: medical chart review
    confirmation of cancer diagnosis
    Other: survey administration
    at baseline enrollment and 12 months post-enrollment
Detailed Description:

OBJECTIVES:

  • To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.
  • To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.

OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Familial pancreatic cancer kindred

Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Has at least 2 blood relatives with pancreatic cancer (both must be related)
    • Has at least 1 blood relative with pancreatic cancer and 1 with melanoma (both must be related)

PATIENT CHARACTERISTICS:

  • Mentally competent and able to provide informed consent
  • Able to understand and read English

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835133

Contacts
Contact: Jodie Cogswell 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gloria M. Petersen, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00835133     History of Changes
Other Study ID Numbers: 355-06, R01CA097075-08, CDR0000613097
Study First Received: January 31, 2009
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
family
history
pancreas
 cancer
melanoma
genetic

Additional relevant MeSH terms:
Pancreatic Diseases
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013