Screening Tests in Detecting Colorectal Cancer - Full Text View

Sponsor:	Mayo Clinic
Collaborators:	National Cancer Institute (NCI) North Central Cancer Treatment Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00025025

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:	Screening, Randomized, Active Control
Official Title:	Colorectal Cancer Screening: Fecal Blood vs. DNA

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Cancer Colorectal Cancer

U.S. FDA Resources

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

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

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Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tuscon, Arizona, United States, 85724
United States, California
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States, 94611
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48100
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
St. John Macomb Hospital
Warren, Michigan, United States, 48903
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
United States, Minnesota
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Investigators

Study Chair:	David A. Ahlquist, MD	Mayo Clinic
Study Chair:	David A. Ahlquist, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009