Colorectal Cancer Screening: Fecal Blood vs. DNA
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.
Interventional
Allocation: Randomized, Primary Purpose: Screening
David A. Ahlquist, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068783
NCT00025025
October 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Eureka Hospital | Eureka, Illinois 61530 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
Mercy Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |