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Recruiting NCT00912717

Pancreatic Adenocarcinoma Gene Environment Risk Study

Observational Pancreatic Cancer

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. 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

The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease

Overview

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Some participants may also be asked to provide a urine sample. Individuals undergoing procedures that require collection of biological samples for clinical purposes may have these samples saved for research purposes. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

Primary outcome measures

  • The data will be used in cohort association studies. Endpoints will depend on the number of patients in the study and the number of markers that are being evaluated. [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed or CT confirmed diagnosis of pancreatic adenocarcinoma
  • Subjects with abnormal imaging study (CT, MRI, MRCP, EUS)
  • Control subjects with a clinical diagnosis of a pancreas, liver, or intestinal condition
  • Control subject with acute pancreatitis
  • Control subject with chronic pancreatitis
  • Control subject with biliary obstruction
  • Control subject with pancreatic cyst
  • Member of a high risk family (≥ 1 close relative with pancreatic cancer)
  • Healthy control (without any of the above conditions)

Exclusion criteria

  • Under the age of 18 years
  • Unable to give informed consent
  • Inability to travel to Pittsburgh for in-person enrollment

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

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT00912717 · STUDY19070256

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗