Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.

Completed

• Conditions: Colo-rectal Cancer

• Registration Number: NCT03741166
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).

Detailed Description

Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Study Timeline

• Study First Submitted: 2018-10-31
• Study Start: 2018-11-08
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-14
• Primary Completion: 2019-04-05
• Study Completion: 2019-04-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 871

Inclusion Criteria

1. Subject is currently enrolled in Exact Sciences Protocol 2018-10
2. Subject is willing and able to provide a blood sample.
3. Subject is willing and able to sign informed consent.

Exclusion Criteria

1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood-based biomarkers associated with genetic and epigenetic alterations.	Point in time blood collection (1 day) at enrollment	Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer.

Trial Locations

Locations (37)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Ventura County Gastroenterology; 🇺🇸 Camarillo, California, United States

Alliance Research Centers; 🇺🇸 Laguna Hills, California, United States

Focilmed; 🇺🇸 Oxnard, California, United States

Desert Oasis Healthcare Medical Group; 🇺🇸 Palm Springs, California, United States

Gastroenterology Associates of Fairfield County; 🇺🇸 Bridgeport, Connecticut, United States

Yale University Section of Digestive Diseases and Liver Diseases; 🇺🇸 New Haven, Connecticut, United States

Precision Clinical Research, LLC; 🇺🇸 Lauderdale Lakes, Florida, United States

Northshore University Health System Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

DM Clinical Research- Southwest Gastroenterology; 🇺🇸 Oak Lawn, Illinois, United States

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