RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for colorectal cancer.

PURPOSE: Randomized screening trial to compare the effectiveness of fecal occult blood testing with that of DNA-based testing of stool and blood in identifying colorectal cancer.

Condition	Treatment or Intervention
Colon Cancer Rectal Cancer	Procedure: colonoscopic studies  Procedure: comparison of screening methods  Procedure: fecal occult blood test for screening  Procedure: screening intervention  Procedure: study of physiologic variables

Further Study Details: 

OBJECTIVES:

• Compare the performance characteristics (sensitivity, specificity, and predictive values) of fecal occult blood (FOB) testing and multitarget DNA-based assay panel (MTAP) testing applied to stools and plasma in identifying colorectal cancer.
• Compare the specificity of the MTAP and FOB tests in participants given pretest dietary restrictions vs no pretest dietary restrictions in order to evaluate the necessity of a formal pretest preparation for MTAP.
• Compare the detection rates of colorectal neoplasia using MTAP alone, flexible sigmoidoscopy alone, and combination sigmoidoscopy and FOB testing.
• Determine the causes of MTAP "false-positive" results, (i.e., positive MTAP and negative colonoscopy).
• Determine and compare the pathological and molecular features of colorectal cancer detected vs not detected by the MTAP.

OUTLINE: This is a randomized, multicenter study. Participants are stratified according to age (50-64 [closed to accrual as of 6/5/03] vs 65-80), gender (male vs female), and participating center. Participants are randomized to one of two screening arms.

• Arm I: Participants eat no red meat and take no nonsteroidal anti-inflammatory drugs (NSAIDs) and no vitamin C or multivitamins for 3 days prior to and during stool sample collection. Participants collect stool samples 3 different times and perform fecal occult blood (FOB) test smears from each stool. After each collection, participants ship the whole stool and FOB test smear to their participating center for blinded multitarget DNA-based assay panel (MTAP) testing.
• Arm II: Participants take no vitamin C or multivitamins for 3 days before and during stool sample collection. Participants collect stool samples and FOB test smears and samples are tested as in arm I. Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy.

PROJECTED ACCRUAL: A total of 4,000 participants (2,000 per arm) will be accrued for this study.

Ages Eligible for Study:  65 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Average risk of colorectal cancer and meets the following criteria:
• More than 1 year since prior fecal occult blood test
• More than 10 years since prior structural colorectal evaluation (i.e., colonoscopy, colon x-ray, or sigmoidoscopy)
• More than 1 month since prior overt rectal bleeding (hematochezia or melena)
• More than 5 years since prior aerodigestive cancer
• No prior colorectal resection
• No contraindications to colonoscopy
• No high-risk conditions for colorectal cancer, such as the following:
• Familial adenomatous polyposis
• Hereditary nonpolyposis colorectal cancer syndrome
• Other hereditary cancer syndromes
• Prior colorectal cancer or adenoma
• Inflammatory bowel disease
• Two or more first-degree relatives with colorectal cancer

PATIENT CHARACTERISTICS: Age:

• 65 to 80

Performance status:

• Not specified

Menopausal status:

• Postmenopausal, with the following qualifications:
• No menstrual period within the past year
• On regular hormone replacement therapy
• Underwent surgical intervention

Life expectancy:

• Not specified

Hematopoietic:

• No coagulopathy

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No serious cardiopulmonary disease

Pulmonary:

• See Cardiovascular

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• More than 3 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• No concurrent therapeutic nonsteroidal anti-inflammatory drugs except prophylactic aspirin (≤ 325 mg/day)
• Concurrent cyclo-oxygenase-2 inhibitors (e.g., celecoxib and rofecoxib) allowed
• No concurrent anticoagulants

Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, TUSCON,  Arizona,  85724,  United States; Recruiting
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
California
      Kaiser Permanente Medical Center - Oakland, Oakland,  California,  94611,  United States; Recruiting
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States; Recruiting
Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting
Michigan
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      Coborn Cancer Center, Saint Cloud,  Minnesota,  56303,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
Ohio
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97239-3098,  United States; Recruiting
      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States; Recruiting
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States; Recruiting

Study chairs or principal investigators

David A. Ahlquist, MD,  Study Chair,  Mayo Clinic Cancer Center   
David A. Ahlquist, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000068783; MAYO-MC9944; NCCTG-MC9944; NCI-P01-0185; NCT00025025
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025025
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08