Clinical trial NCT00830557: Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Islet Cell Tumor
Pancreatic Cancer
Pancreatic Disease
Acute Pancreatitis
Chronic Pancreatitis
Hereditary Pancreatitis
Pancreatic Neuroendocrine Carcinoma
Keywords: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-28
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected pancreas disease including pancreas adenocarcinoma, islet cell cancer, pancreatic cysts, pancreatitis (hereditary, acute, or chronic) or the next of kin of deceased participants.

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.

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.

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

Primary outcomes:
measure: Collection of clinical data, health and family histories by survey
timeFrame: baseline enrollment, 6 months, 12 months
measure: Collection of blood and/or tissue, fecal and oral specimens
timeFrame: baseline
measure: Collection of information regarding food preparation and intake by survey
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shounak Majumder, MD
role: PRINCIPAL_INVESTIGATOR
References: