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Recruiting NCT00830557

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

Observational Islet Cell Tumor Pancreatic Cancer Pancreatic Disease Acute Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: medical chart review, survey administration, biospecimen collection.
Who it may be relevant to
Registry conditions: Islet Cell Tumor, Pancreatic Cancer, Pancreatic Disease, Acute Pancreatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Biospecimen Resource for Pancreas Disease, 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

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To maintain a resource (bank) of biospecimens and data collected from individuals being seen clinically for pancreas conditions to facilitate the discovery and development of (but not limited to) biomarkers of risk (including genomic and proteomic) and early detection as well as novel targeted therapies for pancreatic diseases with a focus on pancreatic cancer.

OUTLINE: This is an observational study.

Patients undergo blood, saliva, and previously obtained leftover tissue sample collection on study. Patients also complete questionnaires and have their medical records reviewed on study.

Interventions

  • Other medical chart review
    baseline, 12 month and 36 months
  • Other survey administration
    baseline, 6 month, 12 month
  • Other biospecimen collection
    baseline

Primary outcome measures

  • Collection of clinical data, health and family histories by survey [Time frame: baseline enrollment, 6 months, 12 months]
  • Collection of blood and/or tissue, fecal and oral specimens [Time frame: baseline]
  • Collection of information regarding food preparation and intake by survey [Time frame: baseline]

Eligibility criteria

  • Known or suspected pancreas disease including:
  • pancreas adenocarcinoma
  • islet cell cancer
  • pancreatic cysts
  • pancreatitis (hereditary, acute, or chronic)
  • Next of kin of deceased participant who did not complete participation before passing away

Exclusion criteria

  • Under the age of 18
  • Unable to provide informed consent
  • Prison inmates

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • Mayo Clinic Hospital in Arizona — Phoenix
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT00830557 · 354-06 · P50CA102701 · CDR0000613100 · U01CA210138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗