NCT00102011

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,952

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started May 2000

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2000

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2005

Completed
21.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

25.8 years

First QC Date

January 18, 2005

Last Update Submit

March 6, 2026

Conditions

Colorectal Cancer

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (5)

  • Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy

    5 years

  • Burden on endoscopic and clinical resources

    5 years

  • Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy

    5 years

  • Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy

    5 years

  • Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy

    5 years

Study Arms (4)

Study I- Arm I

EXPERIMENTAL

Participants undergo baseline screening colonoscopy

Procedure: screening colonoscopy

Study I- Arm II

OTHER

Participants receive standard care

Procedure: fecal occult blood testProcedure: standard follow-up care

Study II- Arm I

EXPERIMENTAL

Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.

Procedure: screening colonoscopy

Study II- Arm II

ACTIVE COMPARATOR

Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.

Procedure: annual screeningProcedure: fecal occult blood test

Interventions

annual screeningPROCEDURE

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

Study II- Arm II
fecal occult blood testPROCEDURE

Participants undergo a baseline fecal occult blood test (FOBT)

Study I- Arm IIStudy II- Arm II
screening colonoscopyPROCEDURE

Patients undergo baseline screening colonoscopy

Study I- Arm IStudy II- Arm I
standard follow-up carePROCEDURE

Standard care

Study I- Arm II

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Masonic Cancer Center at University of Minnesota (Data collection only)

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Kaiser Permanente Washington Health Research Institute (Data collection only)

Seattle, Washington, 98101-1466, United States

Location

Related Publications (3)

  • Shaukat A, Church TR, Shanley R, Kauff ND, O'Brien MJ, Mills GM, Jordan PA, Allen JA, Kim A, Feld AD, Zauber AG, Winawer SJ. Development and validation of a clinical score for predicting risk of adenoma at screening colonoscopy. Cancer Epidemiol Biomarkers Prev. 2015 Jun;24(6):913-20. doi: 10.1158/1055-9965.EPI-14-1321. Epub 2015 Mar 23.

    PMID: 25800242BACKGROUND

  • Mendelsohn RB, Winawer SJ, Jammula A, Mills G, Jordan P, O'Brien MJ, Close GM, Dorfman M, Church TR, Mandelson MT, Allen J, Feld A, Kauff ND, Morgan GA, Kumar JMR, Serrano V, Bayuga-Miller S, Fischer SE, Kuk D, Zauber AG. Adenoma Prevalence in Blacks and Whites Having Equal Adherence To Screening Colonoscopy: The National Colonoscopy Study. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1469-1470. doi: 10.1016/j.cgh.2017.04.014. Epub 2017 Apr 15. No abstract available.

    PMID: 28419856BACKGROUND

  • Zauber AG, Winawer SJ, O'Brien MJ, Mills GM, Allen JI, Feld AD, Jordan PA, Fleisher M, Orlow I, Meester RGS, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, Mandelson M, Shaukat A, Mendelsohn RB, Hahn AI, Lobaugh SM, Soto Palmer B, Serrano V, Kumar JR, Fischer SE, Chen JC, Bayuga-Miller S, Kuk D, O'Connell K, Church TR. Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test. Gastroenterology. 2023 Jul;165(1):252-266. doi: 10.1053/j.gastro.2023.03.206. Epub 2023 Mar 21.

    PMID: 36948424DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ann Zauber, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2005

First Posted

January 19, 2005

Study Start

May 25, 2000

Primary Completion

March 5, 2026

Study Completion

March 5, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(4)