Plasma-based Colorectal Cancer Screening Research & Development
NCT ID: NCT04027790
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
354 participants
OBSERVATIONAL
2019-05-03
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1 - Cancer Patients
Subjects with known colorectal cancer (i.e. AJCC/UICC stages 0, I, II, and III) who provide plasma at least 7 days after diagnosis by colonoscopy, but prior to surgery or treatment
Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
Group 2 - Screening Subjects
Prospectively enrolled subjects reporting for screening colonoscopy who provide a blood sample up to 2 weeks prior to bowel prep and prior to colonoscopy. We accept all subjects who meet the institutional criteria as average risk subjects referred for a screening colonoscopy for colorectal cancer, including subjects undergoing a colonoscopy as a follow-up to a positive (non-colonoscopic) test
Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
Interventions
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Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
Eligibility Criteria
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Inclusion Criteria
* Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality).
* Colonoscopy diagnosis of colorectal cancer (CRC).\*
* Blood sampling a minimum of 7 days after colonoscopy and before resection surgery.
* = Strong clinical suspicion of colorectal carcinoma is also acceptable for subject enrollment; Case must have a confirmed diagnosis after surgery of CRC and be accompanied by a complete final pathology report.
* Willing and able to sign an Informed Consent and adhere to study requirements.
* Eligible for colorectal cancer screening colonoscopy.
* 45 - 84 years of age at blood sampling.
* Able to provide blood sample within up to 2 weeks prior to bowel prep and colonoscopy.
Exclusion Criteria
* Current neoadjuvant treatment.
* Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
* Known infection with HIV, HBV or HCV.
* Previous personal history of CRC, adenomatous polyps \>10mm or sessile serrated adenomas (polyps).
* Familial risk for colorectal cancer (1 or more 1st degree relatives with CRC; known HNPCC or FAP).
* History of inflammatory bowel disease.
* Current neoadjuvant treatment.
* Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
* infection with HIV, HBV or HCV.
45 Years
84 Years
ALL
Yes
Sponsors
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Epigenomics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Theo deVos, PhD
Role: STUDY_DIRECTOR
Epigenomics, Inc
Locations
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University of South Florida
Tampa, Florida, United States
Springfield Clinic
Springfield, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Washington University
St Louis, Missouri, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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ECS0001
Identifier Type: -
Identifier Source: org_study_id
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