Screening Tests in Detecting Colorectal Cancer

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025025
First received: October 11, 2001
Last updated: August 6, 2009
Last verified: August 2005
  Purpose

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 Intervention
Colorectal Cancer
Other: physiologic testing
Procedure: comparison of screening methods
Procedure: fecal occult blood test
Procedure: screening colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Screening
Official Title: Colorectal Cancer Screening: Fecal Blood vs. DNA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025025

  Show 65 Study Locations
Sponsors and Collaborators
Mayo Clinic
North Central Cancer Treatment Group
Investigators
Study Chair: David A. Ahlquist, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00025025     History of Changes
Other Study ID Numbers: CDR0000068783, MAYO-MC9944, NCCTG-MC9944, NCI-P01-0185
Study First Received: October 11, 2001
Last Updated: August 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

ClinicalTrials.gov processed this record on August 20, 2014