ClinicalTrials.gg
RecruitingNCT00899626Updated Mar 5, 2026

Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients

An observational study in Colorectal Cancer, Esophageal Cancer and Gastric Cancer, sponsored by Vanderbilt University Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.

Primary conditionColonic NeoplasmsRegistry: Colorectal NeoplasmsReclassifiedWhy we changed it
Registry
Colorectal Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Colonic Neoplasms
Why
  1. The study's title name Colonic Neoplasms, a narrower term within Colorectal Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy 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 participants undergoing colonoscopy, endoscopy, or surgery.

Read the detailed description

OBJECTIVES:

  • Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and 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 are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

02

Conditions studied

  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Precancerous Condition

Keywords

  • colon cancer
  • gastric cancer
  • pancreatic cancer
  • esophageal cancer
  • adenomatous polyp
03

In context

Colonic Neoplasms Reclassified

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 227 across 555 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Compared within Colonic Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colorectal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Vanderbilt University Medical Center patients with GI malignancy

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center AND
  • Meets 1 of the following criteria:

    • Diagnosis of gastrointestinal (GI) cancer, polyps, or inflammatory bowel disease
    • History of previously treated GI cancer, polyps, or inflammatory bowel disease

PATIENT CHARACTERISTICS:

  • Capable of giving
  • Not mentally or medically impaired
  • No bleeding disorder

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients undergoing colonoscopy, endoscopy, or surgery

    Genomic and proteomic biomarkers

    Time frame: Through study completion, approximately 30 years

  2. Development of new screening strategies based on substances found in tissue and biofluid samples

    Genomic and proteomic biomarker discovery

    Time frame: Through study completion, approximately 30 years

07

Study locations

2 of 2 sites recruiting
  • Veterans Affairs Medical Center - Nashville
    Nashville, Tennessee 37212, United States
    Recruiting
    • Clinical Trials Office - Veterans Affairs Medical Center - Nas · Contact615-327-4751
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
    Recruiting
    • Clinical Trials Office - Vanderbilt-Ingram Cancer Center · Contact800-811-8480
08

References and documents

Publications

  • Smith JJ, Deane NG, Wu F, Merchant NB, Zhang B, Jiang A, Lu P, Johnson JC, Schmidt C, Bailey CE, Eschrich S, Kis C, Levy S, Washington MK, Heslin MJ, Coffey RJ, Yeatman TJ, Shyr Y, Beauchamp RD. Experimentally derived metastasis gene expression profile predicts recurrence and death in patients with colon cancer. Gastroenterology. 2010 Mar;138(3):958-68. doi: 10.1053/j.gastro.2009.11.005. Epub 2009 Nov 13. PubMed 19914252 ↗
  • Oh SC, Park YY, Park ES, Lim JY, Kim SM, Kim SB, Kim J, Kim SC, Chu IS, Smith JJ, Beauchamp RD, Yeatman TJ, Kopetz S, Lee JS. Prognostic gene expression signature associated with two molecularly distinct subtypes of colorectal cancer. Gut. 2012 Sep;61(9):1291-8. doi: 10.1136/gutjnl-2011-300812. Epub 2011 Oct 13. PubMed 21997556 ↗
  • Tripathi MK, Deane NG, Zhu J, An H, Mima S, Wang X, Padmanabhan S, Shi Z, Prodduturi N, Ciombor KK, Chen X, Washington MK, Zhang B, Beauchamp RD. Nuclear factor of activated T-cell activity is associated with metastatic capacity in colon cancer. Cancer Res. 2014 Dec 1;74(23):6947-57. doi: 10.1158/0008-5472.CAN-14-1592. Epub 2014 Oct 15. PubMed 25320007 ↗
  • Zhu J, Deane NG, Lewis KB, Padmanabhan C, Washington MK, Ciombor KK, Timmers C, Goldberg RM, Beauchamp RD, Chen X. Evaluation of frozen tissue-derived prognostic gene expression signatures in FFPE colorectal cancer samples. Sci Rep. 2016 Sep 14;6:33273. doi: 10.1038/srep33273. PubMed 27623752 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2002, a primary completion of Oct 2045 and a completion of Oct 2045. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2009
First posted
May 12, 2009
Start
Jun 2002
Primary completionEst.
Oct 2045
CompletionEst.
Oct 2045
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00899626
Responsible party
Kristen K Ciombor (Associate Professor of Medicine, Vanderbilt University Medical Center) — Principal investigator
First posted
May 12, 2009
Start date
Jun 2002
Primary completion
Oct 2045 (estimated)
Completion
Oct 2045 (estimated)
Last update
Mar 5, 2026

Study contacts

Kristen K Ciombor, MD
Contact
kristen.k.ciombor@vumc.org
6159368422
Keeli B Lewis, BS
Contact
keeli.b.lewis@vumc.org

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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