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Colorectal Cancer Screening: Fecal Blood vs. DNA

65 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Colorectal Cancer Screening: Fecal Blood vs. DNA


- 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

Inclusion Criteria


- 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



- 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


- No coagulopathy


- Not specified


- Not specified


- No serious cardiopulmonary disease


- See Cardiovascular


Biologic therapy:

- Not specified


- More than 3 months since prior chemotherapy

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Screening

Principal Investigator

David A. Ahlquist, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms



Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
CCOP - MeritCare HospitalFargo, North Dakota  58122
Methodist Medical Center of IllinoisPeoria, Illinois  61636
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
St. Luke's HospitalCedar Rapids, Iowa  52402
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
MeritCare Medical GroupFargo, North Dakota  58122
Eureka HospitalEureka, Illinois  61530
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Mercy Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403