Screening Tests in Detecting Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Other: sample testing
- Registration Number
- NCT00025025
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4482
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I sample testing 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. Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy. Arm II sample testing 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (65)
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tuscon, Arizona, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States