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Colorectal CancerNCT00025025

Screening Tests in Detecting Colorectal Cancer

An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
sample testing
How many people
4,482 participants
Where
65 sitesUnited States
Study dates
Oct 2001to Jun 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients aged 65 -80 years

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).
  1. Chemotherapy ≤ 3 months prior to registration.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48100

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80010

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • 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

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Eureka Hospital

    Eureka, Illinois, 61530

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48532

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61615

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tuscon, Arizona, 85724

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • St. John Macomb Hospital

    Warren, Michigan, 48903

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa, 50266

Other trials in United States

About this study

Official title: Colorectal Cancer Screening: Fecal Blood vs. DNA

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.

Read the 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.

Being tested
sample testing
Keywords
colon cancer, rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sample testingOther

Study groups in NCT00025025
Study groupRoleWhat they receive
Arm IParticipants 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. Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy.
Receives: Other: sample testing
Arm IIParticipants 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.
Receives: Other: sample testing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
4,482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025025
Sponsor's protocol ID
NCCTG-MC9944
Other IDs
P30CA015083, MAYO-MC9944, NCCTG-MC9944, NCI-P01-0185
Status last verified
Jul 2016
First submitted
11 Oct 2001
Last updated
4 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00025025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.

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