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Plasma-based Colorectal Cancer Screening Research & Development | Clinical Trials | Clareo Health

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Plasma-based Colorectal Cancer Screening Research & Development

Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development

NCT04027790•Epigenomics, Inc

View on ClinicalTrials.gov

Summary

Detailed Description

The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.

Eligibility

Age

45 - 84 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Willing and able to sign an Informed Consent and adhere to study requirements.
•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

•Subject with curative biopsy during colonoscopy.
•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.

Locations (5)

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

Key Dates

Start Date

May 3, 2019

Primary Completion Date

March 31, 2020

Completion Date

March 31, 2020

Last Updated

February 2, 2021

Enrollment

354

ACTUAL participants

Conditions

Colo-rectal Cancer

Interventions

Epi proColon

DIAGNOSTIC_TEST

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Plasma-based Colorectal Cancer Screening Research & Development

Inclusion Criteria

Exclusion Criteria

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

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