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AzTrials

Colorectal CancerPhase 300-046NCT00102011

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

A Phase 3 study testing annual screening, fecal occult blood test and screening colonoscopy in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
annual screening, fecal occult blood test and screening colonoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,952 participants
Where
4 sitesUnited States
Study dates
25 May 2000to 5 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Kaiser Permanente Washington Health Research Institute (Data collection only)

    Seattle, Washington, 98101-1466

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

Other trials in United States

About this study

Official title: Colonoscopy Screening Trial

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.

Read the detailed description

OBJECTIVES:

  • Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests.
  • Compare the endoscopic and clinical resources required for these screening methods in these participants.
  • Compare the benefit-to-harm ratio in participants undergoing these screening methods.
  • Determine the level of participation of participants undergoing these screening methods.

OUTLINE: This is a randomized, two-part, multicenter study.

Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening.

  • Screening colonoscopy feasibility study I (accrual completed as of 12/14/2004): Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.
  • Arm I: Participants undergo baseline screening colonoscopy.
  • Arm II: Participants receive standard care.
  • Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.
  • Arm I: Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
  • Arm II: 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.

All participants are followed annually for up to 4 years.

PROJECTED ACCRUAL: A total of 1,402 participants (701 per screening arm) have been accrued for feasibility study I within 3 years (accrual completed as of 12/14/2004). An additional 3,550 participants (1,775 per screening arm) will be accrued for feasibility study II within 5 years.

Being tested
annual screening, fecal occult blood test, screening colonoscopy, standard follow-up care
Keywords
colon cancer, rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • annual screeningProcedure or surgery

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

  • fecal occult blood testProcedure or surgery

    Participants undergo a baseline fecal occult blood test (FOBT)

  • screening colonoscopyProcedure or surgery

    Patients undergo baseline screening colonoscopy

  • standard follow-up careProcedure or surgery

    Standard care

Study groups in NCT00102011
Study groupRoleWhat they receive
Study I- Arm IExperimentalParticipants undergo baseline screening colonoscopy
Receives: Procedure: screening colonoscopy
Study I- Arm IIOtherParticipants receive standard care
Receives: Procedure: fecal occult blood test; Procedure: standard follow-up care
Study II- Arm IExperimentalParticipants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
Receives: Procedure: screening colonoscopy
Study II- Arm IIActive comparatorParticipants 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.
Receives: Procedure: annual screening; Procedure: fecal occult blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 years

  2. Burden on endoscopic and clinical resources

    Measured: 5 years

  3. Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy

    Measured: 5 years

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

    Measured: 5 years

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2005 (estimated)
  2. Study start25 May 2000
  3. Primary completion5 Mar 2026
  4. Study completion5 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,952 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102011
Sponsor's protocol ID
00-046
Other IDs
MSKCC-00046A, UMN-2003NT062
Acronym
00-046
Status last verified
Mar 2026
First submitted
18 Jan 2005
Last updated
9 Mar 2026
Results posted
No

Publications

  • 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.

    PubMed 25800242

  • 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.

    PubMed 28419856

  • 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.

    PubMed 36948424

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing annual screening, fecal occult blood test and screening colonoscopy in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00102011, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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