Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

NCT01511653 | Completed

• 1 other identifier: GLNE010
• Study Type: observational
• Target: 13,000
• Locations: 3 countries
• Sites: 9

Brief Summary

The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.

Conditions

Colon Cancer; Rectal Cancer

Keywords

screening colonoscopy; colon cancer early detection; rectal cancer early detection; colorectal cancer prevention; biomarker validation

Outcome Measures

Primary Outcomes (1)

• Measure the sensitivity of a blood based panel of biomarkers relative to fecal immunochemical testing

  Test the hypothesis that sensitivity of stool vimentin methylation and/ the blood based panel (serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA) when combined with fecal immunochemical testing (FIT) will significantly improve the sensitivity of FIT for the detection of colorectal adenocarcinoma, and maintain specificity greater than 0.80.

  12 weeks from enrollment to completion of colonoscopy

Secondary Outcomes (2)

• To measure the specificity of a blood based panel of biomarkers relative to fecal immunochemical testing

  12 weeks from enrollment to completion of colonoscopy

• To measure the sensitivity and specificity of a combined panel of blood and stool based biomarkers for the detection of colorectal cancer

  12 weeks from enrollment to completion of colonoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

13000 asymptomatic subjects aged 50-80 undergoing routine colonoscopic screening for colorectal cancer from community and major medical center outpatient settings across multiple centers and consortia will be recruited.

You may qualify if:

• Adults 40\*+ undergoing a first time colonoscopy for screening OR
• Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in the past 12 months (365 days)
• Willing to sign informed consent
• Able to physically tolerate removal of 50 ml of blood
• Willing to collect 2 stool samples
• (\*age 60 and up in U.S., 50 and up outside US)

You may not qualify if:

• Inability to provide informed consent
• History of Inflammatory Bowel Disease
• Overt rectal bleeding within 1 month (30 days) (including due to suspected hemorrhoids)
• Undergone resection of the colon for any indication
• Subjects with known HIV or chronic viral hepatitis (Hepatitis B and C)
• Subjects with known or suspected HNPCC (Lynch Syndrome) or FAP
• Any 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 , 0, I or Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

Sponsors & Collaborators

• University of Michigan: lead
• Early Detection Research Network: collaborator

Study Sites (9)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55113, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Calgary-Colon Cancer Screening Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

German Cancer Research Center (DKFZ)

Heidelberg, 69120, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two 10 ml red top (serum) tubes Three 10 ml purple top (EDTA)tubes 25 ml of urine 2 Fecal Immunohistochemical Tests (FIT) Stool

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dean E Brenner, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Internal Medicine

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 18, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

CA (1); US (7); DE (1)