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NCT00102011CompletedPhase 3

Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

Colonoscopy Screening Trial

Source: ClinicalTrials.gov · Last updated 9 Mar 2026

Brief summary (registry, in English)

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer. PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
4952 (estimated)
First submitted
18 Jan 2005
Start date
25 May 2000
Primary completion date
5 Mar 2026
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT00102011

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 4952
  • From 25 May 2000 to the primary completion date, 5 Mar 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • DISEASE CHARACTERISTICS:
  • Healthy participants at average risk for developing colorectal cancer
  • No history of colorectal cancer
  • No history of familial adenomatous polyposis
  • More than 5 years since prior flexible sigmoidoscopy
  • No prior colonoscopy
    • PATIENT CHARACTERISTICS:
    • Age
  • 50 to 69 (40 to 69 at the Louisiana State University participating site)
    • Performance status
  • Not specified
    • Life expectancy
  • Not specified
    • Hematopoietic
  • Not specified
    • Hepatic
  • Not specified
    • Renal
  • Not specified
    • Cardiovascular
  • No myocardial infarction within the past year
  • No congestive heart failure
    • Pulmonary
  • No chronic obstructive pulmonary disease
    • Gastrointestinal
  • No history of ulcerative colitis
  • No history of Crohn's disease
  • No history of inflammatory bowel disease
    • Other
  • No serious comorbid condition
  • No consumption of red meat within 3 days prior to and during FOBT (feasibility study II, arm II only)
    • PRIOR CONCURRENT THERAPY:
    • Biologic therapy
  • Not specified
    • Chemotherapy
  • No concurrent chemotherapy other than for nonmelanoma skin cancer
    • Endocrine therapy
  • Not specified
    • Radiotherapy
  • Not specified
    • Surgery
  • Not specified
    • Other
  • No vitamin C consumption \> 250 mg within 3 days prior to and during fecal occult blood testing (FOBT) (feasibility study II arm II only)
  • No nonsteroidal anti-inflammatory drugs within 7 days prior to and during FOBT (feasibility study II, arm II only)
  • No concurrent anticoagulants
  • No concurrent anticancer therapy except for treatment of nonmelanoma skin cancer

Age in the registry: 40 years to 69 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Masonic Cancer Center at University of Minnesota (Data collection only)
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Kaiser Permanente Washington Health Research Institute (Data collection only)
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Coordinator of this site? Confirm its status
ShreveportUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.