Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma (GLNE010)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The investigators are undertaking a multi-center, 6000 subject validation study of several biomarkers for early detection of colon cancer. There are 2 stool based biomarkers (one is a panel) and 1 serum based biomarker 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 or routine surveillance. 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 from all sites using prepaid UPS mailing labels.
| Condition |
|---|
|
Colon Cancer Rectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma |
- Compare biomarkers to colonoscopy as a predictor of CRC risk [ Time Frame: baseline ] [ Designated as safety issue: No ]To validate various biomarkers (stool, blood, urine, FIT) as predictive tools for assessing risk of CRC. Ultimately, these markers may increasing screening and compliance with screening recommendations of CRC by triaging those at higher risk of CRC by thesenon-invasive markers. Those at higher risk of CRC based on biomarker results would be referred for colonoscopy. The assumption is that compliance with colonoscopy would increase if biomarkers suggested an increased risk.
Biospecimen Retention: Samples With DNA
Two 10 ml red top (serum) tubes Two 7 ml purple top (EDTA)tubes 100 ml of urine 2 Fecal Immunohistochemical Tests (FIT)
1 stool bucket
| Estimated Enrollment: | 6000 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
5.0 STUDY DESIGN 5.1 Subject Recruitment The clinical research associate or study nurse (hereafter "CRA") at each clinical site will identify subjects with appointments for screening colonoscopy via IRB-approved HIPAA-compliant site-specific methods (Appendix B-tailored to each site). Recruitment methods could include letters from the primary care physicians and gastroenterologists, direct referrals to the study team by physicians, in-clinic recruitment advertisements, and presentations. Interested subjects will be asked to participate in a baseline visit prior to initiation of colonoscopy preparative procedures, either at the local Center or during a visit to the subject's home by a CRA. Advertisements (e.g., newspapers, AARP Magazine, Clinicaltrials.gov) may also be used to recruit subjects from the surrounding communities.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
6000 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.
Inclusion Criteria:
Adults 50-80 and undergoing a colonoscopy defined as:
- First time screening or a surveillance procedure
- No complete colon exam (colonoscopy or CT colonography) within 3 years except as noted. (see section 5.4.1)
- Willing to sign informed consent
- Able to physically tolerate removal of 34ml of blood
- Willing to collect 2 stool samples
Exclusion Criteria:
- Inability to provide informed consent
- History of Inflammatory Bowel Disease
- Overt rectal bleeding within 1 month (30 days) (including due to suspected hemorrhoids)
- Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in the past 12 months (365 days)
- 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
Contacts and Locations| Contact: Missy Tuck, M.S. | 734-763-1141 | glne010@umich.edu |
| United States, Illinois | |
| University of Illinois-Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Missy Tuck, M.S. 734-763-1141 glne010@umich.edu | |
| Principal Investigator: Robert Carroll, M.D. | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Missy Tuck glne010@umich.edu | |
| Principal Investigator: Sapna Syngal, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Missy Tuck, MS 734-763-1141 glne010@umich.edu | |
| Principal Investigator: Kim Turgeon, MD | |
| Sub-Investigator: Dean Brenner, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55113 | |
| Contact: Missy Tuck, M.S. 734-763-1141 glne010@umich.edu | |
| Principal Investigator: Timothy Church, PhD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Missy Tuck glne010@umich.edu | |
| Principal Investigator: Fay Castrinos, MD | |
| Mt. Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Missy Tuck glne010@umich.edu | |
| Principal Investigator: Sharmila Anandasapathy, MD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Missy Tuck, M.S. 734-763-1141 glne010@umich.edu | |
| Principal Investigator: John Baron, M.D. | |
| United States, Ohio | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Missy Tuck, M.S. 734-763-1141 glne010@umich.edu | |
| Principal Investigator: Li Li, PhD | |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Missy Tuck, MS glne010@umich.edu | |
| Principal Investigator: Robert Bresalier, MD | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Missy Tuck 734-763-1141 glne010@umich.edu | |
| Principal Investigator: William Grady, M.D. | |
| Canada, Ontario | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Missy Tuck glne010@umich.edu | |
| Principal Investigator: Norman Marcon, MD | |
More Information
No publications provided
| Responsible Party: | Missy Tuck, Project Manager, Clinical Research, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01511653 History of Changes |
| Obsolete Identifiers: | NCT01585363 |
| Other Study ID Numbers: | GLNE010 |
| Study First Received: | January 6, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Michigan:
|
screening colonoscopy colon cancer early detection rectal cancer early detection colorectal cancer prevention biomarker validation |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013