Screening Tests in Detecting Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      Primary objectives:

        1. To compare the performance characteristics (sensitivity, specificity, predictive values)
           of the fecal MTAP and most widely-used fecal occult blood test (Hemoccult) for
           identification of screen-relevant colorectal neoplasia (curablestage cancer and advanced
           adenomas with high-grade dysplasia/carcinoma in situ or size ≥ 1.0 cm.)

        2. To evaluate the necessity of formal pretest preparation for MTAP by comparing the
           specificity of both the MTAP and Hemoccult tests in subject groups randomized to
           pre-test preparation versus no pre-test preparation.

      Secondary objectives:

        1. To compare detection rates of colorectal neoplasia by the fecal MTAP alone with those by
           flexible sigmoidoscopy (distal 60 cm of colonoscopic examination to serve as surrogate)
           and by the combination of sigmoidoscopy plus Hemoccult.

        2. To characterize and compare the pathological and molecular features of screen-relevant
           colorectal neoplasms detected and not detected by the fecal MTAP.

        3. To explore the sensitivity and specificity of the MTAP applied to plasma for the
           detection of screen-relevant colorectal neoplasia.

        4. To maintain a specimen bank comprising stools and blood (plasma) from all subjects and
           tissue from screen-relevant neoplasms.

      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.
    

Intervention name(s): sample testing
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 65 -80 years
      
Keywords: colon cancer; rectal cancer