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Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (00-046)

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ClinicalTrials.gov Identifier: NCT00102011
Recruitment Status : Active, not recruiting
First Posted : January 19, 2005
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: annual screening Procedure: fecal occult blood test Procedure: screening colonoscopy Procedure: standard follow-up care Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4952 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Colonoscopy Screening Trial
Study Start Date : May 2000
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study I- Arm I
Participants undergo baseline screening colonoscopy
 Procedure: screening colonoscopy
Patients undergo baseline screening colonoscopy
Study I- Arm II
Participants receive standard care
 Procedure: fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
Procedure: standard follow-up care
Standard care
Experimental: Study II- Arm I
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
 Procedure: screening colonoscopy
Patients undergo baseline screening colonoscopy
Active Comparator: Study II- 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.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy [ Time Frame: 5 years ]
  2. Burden on endoscopic and clinical resources [ Time Frame: 5 years ]
  3. Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy [ Time Frame: 5 years ]
  4. Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy [ Time Frame: 5 years ]
  5. Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102011


Locations
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Washington
Group Health Central Hospital
Seattle, Washington, United States, 98112
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Ann Zauber, PhD Memorial Sloan Kettering Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00102011     History of Changes
Other Study ID Numbers: 00-046
MSKCC-00046A
UMN-2003NT062
First Posted: January 19, 2005    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases