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  • First Published: 4/23/2012
  • Last Modified: 5/24/2013

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Study of Biomarkers for Early Detection of Colorectal Adenocarcinoma in Adults Undergoing Colonoscopy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Biomarkers for Early Detection of Colorectal Cancer in Adults Undergoing Colonoscopy

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, ScreeningActive50 to 80NCINCCTG-GLNE010
GLNE 010, GLNE010, NCT01511653

Objectives

Primary

  1. To determine if the sensitivity of stool vimentin methylation is greater than that for fecal immunochemical testing (FIT) for the detection of the combined endpoint of colorectal adenocarcinoma or adenomas with high-grade dysplasia, at the same specificity of stool vimentin methylation test.
  2. To estimate the sensitivity and specificity for colorectal adenocarcinoma and high-grade dysplasia, or screen relevant neoplasms (SRN) (colorectal adenocarcinoma, high-grade dysplasia, and adenomas ≥ 1 cm) of individual colorectal neoplasia early-detection biomarkers using colonoscopy as the gold standard.

Secondary

  1. To estimate the sensitivity and specificity of the individual binary biomarkers (stool vimentin methylation, serum galectin-3 ligand, and the Exact Sciences stool DNA panel) in combination with FIT for colorectal adenocarcinoma and high-grade dysplasia, and for screen relevant neoplasms.
  2. To test the null hypothesis that the sensitivities of the combined tests described above are equal or lower than a minimally acceptable value (MAV) versus the alternative that they are higher than the MAV, with the MAV set as 70% for the detection of colorectal adenocarcinoma and high-grade dysplasia and 45% or higher for SRN, with fixed specificities.
  3. To construct a combined early-detection biomarker score of individual biomarkers (stool vimentin methylation, serum galectin-3 ligand, FIT and the Exact Sciences stool DNA panel) using logistic regression, and to describe its performance for colorectal adenocarcinoma, high-grade dysplasia, and SRN.
  4. To establish an archive of appropriately preserved stool, serum, plasma, and DNA human biospecimens to be used by Early Detection Research Network- (EDRN) approved investigators for future validation and biomarker discovery research.

Entry Criteria

Disease Characteristics:

  • Adults 50-80 years of age undergoing a colonoscopy defined as:
    • First-time screening or a surveillance procedure (colonoscopy cannot be for any therapeutic or diagnostic reason)
    • No complete colon exam (colonoscopy or CT colonography) within 3 years

  • No positive guiaiac-based occult blood or fecal immunochemical test (e.g., fecal occult blood test [FOBT] or fecal immunochemical testing [FIT] ) in the past 12 months

  • No hereditary nonpolyposis colorectal cancer (HNPCC [Lynch syndrome]) or familial adenomatous polyposis (FAP)

Prior/Concurrent Therapy:

  • Has not undergone resection of the colon for any indication
  • No complete colonoscopy within the past 3 years
    • Prior flexible sigmoidoscopy allowed

Patient Characteristics:

  • Able to physically tolerate removal of 34 mL of blood
  • Willing to collect 2 stool samples
  • No history of inflammatory bowel disease
  • No overt rectal bleeding within 1 month (30 days) (including due to suspected hemorrhoids)
  • No subjects with known HIV or chronic viral hepatitis (hepatitis B or C)
  • No cancer within 5 years of enrollment except any of the following:
    • Squamous cell carcinoma of the skin or basal cell carcinoma of the skin
    • Carcinoma in situ of the cervix, stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only (excluded if had pelvic radiation)
    • Stage IA grade 1 adenocarcinoma of the endometrium treated with surgery

Expected Enrollment

6000

Outcomes

Primary Outcome(s)

Sensitivity of stool vimentin methylation test greater than that for fecal immunochemical testing (FIT)

Secondary Outcome(s)

Sensitivity and specificity of the individual binary biomarkers (stool vimentin methylation, serum galectin-3 ligand, and the Exact Sciences stool DNA panel) in combination with FIT to detect colorectal adenocarcinoma, high-grade dysplasia, and relevant neoplasms
Sensitivities of the combined tests are equal or lower than a minimally acceptable value (MAV)
Combined biomarkers for early detection of colorectal adenocarcinoma, high-grade dysplasia, and relevant neoplasms

Outline

This is a multicenter study.

Participants undergo serum, plasma, and urine samples collection within 12 weeks prior to colonoscopy. Participants receive detailed instructions and complete kits to collect stool samples at home prior to beginning colon preparation procedures. They also receive detailed instructions on how to prepare the Fecal Immunochemical Test (FIT) tests. Participants then pack and ship the stools samples and the FIT test, per shipping instructions, to the Central Biosample Laboratory at the University of Michigan using a pre-paid Department of Transportation-compliance packaging. Participants with detectable colorectal adenocarcinoma, high-grade dysplasia, and adenomas at the time of colonoscopy undergo tissue sample collection.

Samples are analyzed for presence of methylated vimentin gene, fecal immunochemical test, galectin-3 ligand, DNA panel of genetic biomarker and other unspecified biomarkers by qualitative tests, FOBT-CHEKoc®, ELISA, qInvader (multiplexed rtPCR assay), and immuno-hemoglobulin (ELISA-based) assay.

Patients complete the NIH Health Diet Health II Food Frequency Questionnaire, the Early Detection Research Network (EDRN) demographic, and medical history questionnaires at baseline.

After completion of colonoscopy, patients are followed up by telephone, e-mail, or letter for 1 year.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Principal investigator
Ph: 507-284-8964

Trial Sites

U.S.A.
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979
 Tripler Army Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
Illinois
  Chicago
 Louis A. Weiss Memorial Hospital
 Clinical Trials Office - Louis A. Weiss Memorial Hospital
Ph: 773- 564-5044
  Urbana
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Kansas
  Wichita
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Michigan
  Grand Rapids
 CCOP - Grand Rapids
 Gilbert Padula
Ph: 616-391-1230
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus
Ph: 248-551-7695
Minnesota
  Duluth
 CCOP - Duluth
 Steven Kuross
Ph: 218-786-8364
New York
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
North Dakota
  Fargo
 MeritCare Broadway
 Preston Steen, MD
Ph: 701-234-2397
Ohio
  Franklin
 Middletown Regional Hospital
 Albert Malcolm
Ph: 513-424-2111
Oklahoma
  Oklahoma City
 Cancer Care Associates - Mercy Campus
 Vikki Canfield, MD
Ph: 405-751-4343
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 Michael Kayser
Ph: 918-494-2273
South Carolina
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Clinical Trials Office - Gibbs Regional Cancer Center
Ph: 800-486-5941
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Clinical Trials Office - Gundersen Lutheran Cancer Center
Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marshfield
 Marshfield Clinic - Marshfield Center
 Clinical Trials Office - Marshfield Clinic - Marshfield Center
Ph: 800-782-1581 ext. 94457

Registry Information
Official Title Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma
Trial Start Date 2012-04-23
Trial Completion Date 2012-09-30 (estimated)
Registered in ClinicalTrials.gov NCT01511653
Date Submitted to PDQ 2011-07-11
Information Last Verified 2013-05-24
NCI Grant/Contract Number CA86400-11

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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