Clinical trial NCT00025025: Screening Tests in Detecting Colorectal Cancer
Official title: Colorectal Cancer Screening: Fecal Blood vs. DNA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Mayo Clinic
First posted: 2003-01-27
Enrollment: 4482
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 -80 years

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.

Eligibility criteria: Required Characteristics:

1. ≥ 65 and ≤ 80 years of age.
2. Females must be postmenopausal (absence of menstrual periods for at least one year; patients on regular hormone replacement therapy; surgical intervention).

Contraindications:

1. FOBT screening ≤1 year prior to randomization.
2. Structural colorectal evaluation (i.e. colonoscopy, colon x-ray, or sigmoidoscopy) ≤10 years prior to randomization.
3. Overt rectal bleeding (hematochezia or melena) ≤1 month prior to randomization.
4. Prior colorectal resection for any reason.
5. Inability to stop therapeutic doses of NSAIDs (prophylactic doses of aspirin (≤325 mg) allowed \[121\] and Cox2 inhibitors (i.e. Celebrex, Vioxx) allowed.)
6. Coagulopathy or inablitity to discontinue anticoagulants (discontinuation must be superviesed by a physician).
7. Aerodigestive cancer ≤5 years prior to randomization.
8. Contraindications to colonoscopy (e.g., serious cardiopulmonary disease).
9. High-risk conditions for colorectal cancer (familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer syndrome, other hereditary cancer syndromes, prior colorectal cancer or adenoma, inflammatory bowel disease, and

   * 2 first-degree relatives with colorectal cancer).
10. Chemotherapy ≤ 3 months prior to registration.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center - Oakland
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center
state: Colorado
city: Aurora
country: United States
facility: Rush-Copley Cancer Care Center
state: Illinois
city: Bloomington
country: United States
facility: St. Joseph Medical Center
state: Illinois
city: Canton
country: United States
facility: Graham Hospital
state: Illinois
city: Carthage
country: United States
facility: Memorial Hospital
state: Illinois
city: Eureka
country: United States
facility: Eureka Hospital
state: Illinois
city: Galesburg
country: United States
facility: Galesburg Clinic
state: Illinois
city: Galesburg
country: United States
facility: Galesburg Cottage Hospital
state: Illinois
city: Galesburg
country: United States
facility: InterCommunity Cancer Center of Western Illinois
state: Illinois
city: Havana
country: United States
facility: Mason District Hospital
state: Illinois
city: Hopedale
country: United States
facility: Hopedale Medical Complex
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates, Limited - West
state: Illinois
city: Kewanee
country: United States
facility: Kewanee Hospital
state: Illinois
city: Macomb
country: United States
facility: McDonough District Hospital
state: Illinois
city: Normal
country: United States
facility: BroMenn Regional Medical Center
state: Illinois
city: Normal
country: United States
facility: Community Cancer Center
state: Illinois
city: Ottawa
country: United States
facility: Community Hospital of Ottawa
state: Illinois
city: Ottawa
country: United States
facility: Oncology Hematology Associates of Central Illinois - Ottawa
state: Illinois
city: Pekin
country: United States
facility: Cancer Treatment Center at Pekin Hospital
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peoria
country: United States
facility: Proctor Hospital
state: Illinois
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Peoria
country: United States
facility: Oncology/Hematology Associates of Central Illinois, P.C.
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Peru
country: United States
facility: Illinois Valley Community Hospital
state: Illinois
city: Princeton
country: United States
facility: Perry Memorial Hospital
state: Illinois
city: Spring Valley
country: United States
facility: St. Margaret's Hospital
state: Illinois
city: Spring Valley
country: United States
facility: Valley Cancer Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center at Carle Foundation Hospital
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Michigan City
country: United States
facility: Saint Anthony Memorial Health Centers
state: Indiana
city: Cedar Rapids
country: United States
facility: St. Luke's Hospital
state: Iowa
city: Cedar Rapids
country: United States
facility: Cedar Rapids Oncology Associates
state: Iowa
city: Cedar Rapids
country: United States
facility: Mercy Cancer Center at Mercy Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Capitol Hospital
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Des Moines
country: United States
facility: John Stoddard Cancer Center at Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates at John Stoddard Cancer Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates at Mercy Cancer Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Cancer Center at Mercy Medical Center - Des Moines
state: Iowa
city: Des Moines
country: United States
facility: John Stoddard Cancer Center at Iowa Lutheran Hospital
state: Iowa
city: West Des Moines
country: United States
facility: Medical Oncology and Hematology Associates - West Des Moines
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Cancer Institute at Ochsner Clinic Foundation
state: Louisiana
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Cancer Center at Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: Van Elslander Cancer Center at St. John Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Lansing
country: United States
facility: Sparrow Regional Cancer Center
state: Michigan
city: Saginaw
country: United States
facility: Seton Cancer Institute - Saginaw
state: Michigan
city: Warren
country: United States
facility: St. John Macomb Hospital
state: Michigan
city: Bemidji
country: United States
facility: MeritCare Clinic - Bemidji
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: St. Cloud
country: United States
facility: CentraCare Clinic - River Campus
state: Minnesota
city: Fargo
country: United States
facility: CCOP - MeritCare Hospital
state: North Dakota
city: Fargo
country: United States
facility: MeritCare Medical Group
state: North Dakota
city: Portland
country: United States
facility: Veterans Affairs Medical Center - Portland
state: Oregon
city: Portland
country: United States
facility: Cancer Institute at Oregon Health and Science University
state: Oregon
city: Sioux Falls
country: United States
facility: Sioux Valley Hospital and University of South Dakota Medical Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital and University Health Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Medical X-Ray Center
state: South Dakota
Study officials:
affiliation: Mayo Clinic
name: David A. Ahlquist, MD
role: STUDY_CHAIR
References: