Screening Tests in Detecting Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Screening: Fecal Blood vs. DNA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025025
• Other study ID #: NCCTG-MC9944
• Secondary ID: P30CA015083MAYO-
• Status: Completed
• Phase: N/A
• First received: October 11, 2001
• Last updated: July 1, 2016
• Start date: October 2001
• Est. completion date: June 2009

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4482
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• sample testing

Locations

Country	Name	City	State
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	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	MeritCare Clinic - Bemidji	Bemidji	Minnesota
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	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	Mercy Capitol Hospital	Des Moines	Iowa
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Detroit	Michigan
United States	Eureka Hospital	Eureka	Illinois
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Medical Group	Fargo	North Dakota
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
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	Mason District Hospital	Havana	Illinois
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Kewanee Hospital	Kewanee	Illinois
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	McDonough District Hospital	Macomb	Illinois
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
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	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	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	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Seton Cancer Institute - Saginaw	Saginaw	Michigan
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Medical X-Ray Center	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	CentraCare Clinic - River Campus	St. Cloud	Minnesota
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tuscon	Arizona
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	St. John Macomb Hospital	Warren	Michigan
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	Mayo Clinic, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,