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

NCT00102011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4952

Last updated 2026-03-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

annual screening

Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT

PROCEDURE

fecal occult blood test

Participants undergo a baseline fecal occult blood test (FOBT)

PROCEDURE

screening colonoscopy

Patients undergo baseline screening colonoscopy

PROCEDURE

standard follow-up care

Standard care

Sponsors & Collaborators

Principal Investigators

  • Ann Zauber, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-05-25
Primary Completion
2026-03-05
Completion
2026-03-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102011 on ClinicalTrials.gov