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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Memorial Sloan-Kettering Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00102011
First received: January 18, 2005
Last updated: July 6, 2012
Last verified: July 2012

January 18, 2005
July 6, 2012
May 2000
May 2013   (final data collection date for primary outcome measure)
  • Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Burden on endoscopic and clinical resources [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00102011 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Colorectal Cancer
  • 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
  • Experimental: Study I- Arm I
    Participants undergo baseline screening colonoscopy
    Intervention: Procedure: screening colonoscopy
  • No Intervention: Study I- Arm II
    Participants receive standard care
    Intervention: Procedure: standard follow-up 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.
    Intervention: Procedure: 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.
    Interventions:
    • Procedure: annual screening
    • Procedure: fecal occult blood test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4952
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 69 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102011
CDR0000413897, MSKCC-00046A, UMN-2003NT062
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Ann Zauber, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP