Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants

  • STATUS
    Recruiting
  • End date
    Oct 22, 2030
  • participants needed
    1000
  • sponsor
    Vanderbilt University Medical Center
Updated on 22 July 2022
cancer
endoscopy
screening colonoscopy
primary cancer
diagnostic endoscopic surgery
diagnostic endoscopic procedure
Accepts healthy volunteers

Summary

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy participants may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and healthy participants undergoing colonoscopy, endoscopy, or surgery.

Description

OBJECTIVES
  • Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and healthy volunteers undergoing colonoscopy, endoscopy, or surgery.
  • Develop new screening strategies based on substances found in tissue and biofluid samples.

OUTLINE: This is a multicenter study.

Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g., blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample collection. Samples are analyzed for tumor markers by proteomic methods and protein analysis. If candidate biomarkers are identified, samples are stored for future studies involving these biomarkers. Information, including demographics, personal and family history of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected from the medical record and stored in the project database.

Patients and healthy volunteers are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

Details
Condition Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Precancerous Condition
Treatment laboratory biomarker analysis, medical chart review, biologic sample preservation procedure, proteomic profiling, screening colonoscopy, protein analysis, diagnostic colonoscopy, diagnostic endoscopic procedure, diagnostic endoscopic surgery, diagnostic surgical procedure, endoscopic surgery, endoscopic surgery
Clinical Study IdentifierNCT00899626
SponsorVanderbilt University Medical Center
Last Modified on22 July 2022

Eligibility

How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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