Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT03821948
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

Detailed Description

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-30
• Primary Completion: 2020-02-28
• Study Completion: 2020-05-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5131

Inclusion Criteria

• Subject is male or female, 40 years of age or older.
• Subject is at average or increased risk for development of CRC.
• Subject presents for screening or surveillance colonoscopy.
• Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria

• Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.

• Subject has a diagnosis or personal history of any of the following conditions, including:

  1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.

• Subject has a family history of:

  1. Familial adenomatous polyposis (also referred to as "FAP").
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").

• Subjects with Cronkhite-Canada Syndrome.

• IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

• 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
Stool-based biomarkers associated with genetic and epigenetic alterations	Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.	The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
Blood-based biomarkers associated with genetic and epigenetic alterations.	Point in time blood collection (1 day) at enrollment.	The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.

Trial Locations

Locations (36)

CCT Research/Fiel Family and Sports Medicine; 🇺🇸 Tempe, Arizona, United States

GW Research, Inc; 🇺🇸 Chula Vista, California, United States

Marvel Research, LLC; 🇺🇸 Huntington Beach, California, United States

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

Great Lakes Medical Research, LLC; 🇺🇸 Union City, Tennessee, United States

Connecticut Clinical Research Institute, LLC; 🇺🇸 Hartford, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Guardian Angel Research Center; 🇺🇸 Tampa, Florida, United States

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

Margaret Mary Health; 🇺🇸 Batesville, Indiana, United States

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