Screening Tests in Detecting Colorectal Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Study Start Date: | October 2001 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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 |
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
Show 65 Study Locations| 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 May 23, 2013