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Completed

NCT Number: NCT03741166

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

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).

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Blood Sample Collection

Other

Subjects participating in the study will have blood drawn at enrollment.

Primary outcomes

  1. Blood-based biomarkers associated with genetic and epigenetic alterations.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Official study title

Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: "An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now"

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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