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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821948
• Other study ID #: 2018-08
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: May 15, 2020

Study information

• Verified date: July 2020
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5131
• Est. completion date: May 15, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United States	Digestive Health Partners, PA	Asheville	North Carolina
United States	MediSync Clinical Research	Austin	Texas
United States	Margaret Mary Health	Batesville	Indiana
United States	Great Lakes Medical Research	Beachwood	Ohio
United States	Charlotte Gastroenterology and Hepatology, LLC	Charlotte	North Carolina
United States	GW Research, Inc	Chula Vista	California
United States	Northside Gastroenterology	Cypress	Texas
United States	Great Lakes Medical Research, LLC	East Lansing	Michigan
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Centennial Medical Group	Elkridge	Maryland
United States	Great Lakes Medical Research	Erie	Pennsylvania
United States	Deaconess Clinic-Mt. Pleasant	Evansville	Indiana
United States	Susquehanna Research Group	Harrisburg	Pennsylvania
United States	Connecticut Clinical Research Institute, LLC	Hartford	Connecticut
United States	Digestive Health Associates	Houston	Texas
United States	Vilo Research Group, Inc	Houston	Texas
United States	Marvel Research, LLC	Huntington Beach	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	DM Clinical Research/PCP For Life	Magnolia	Texas
United States	Family Practice Center of Wooster, Inc./Clinical Trial Developers	Massillon	Ohio
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	New Orleans Research Institute	Metairie	Louisiana
United States	Delta Research Partners	Monroe	Louisiana
United States	Yale University	New Haven	Connecticut
United States	Digestive Disease Care, PC	New Hyde Park	New York
United States	Deaconess Clinic-Gateway	Newburgh	Indiana
United States	DM Clinical Research/Southwest Gastroenterology	Oak Lawn	Illinois
United States	Desert Medical Group Inc	Palm Springs	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Capitol Research	Rockville	Maryland
United States	Great Lakes Medical Research, LLC	San Diego	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Virginia Gastroenterology Institute	Suffolk	Virginia
United States	Guardian Angel Research Center	Tampa	Florida
United States	CCT Research/Fiel Family and Sports Medicine	Tempe	Arizona
United States	Great Lakes Medical Research, LLC	Union City	Tennessee
United States	Wenatchee Valley Hospital	Wenatchee	Washington
United States	Great Lakes Medical Research, LLC	Westlake	Ohio
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Comprehensive Internal Medicine, Inc	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool-based biomarkers associated with genetic and epigenetic alterations	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.	Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
Primary	Blood-based biomarkers associated with genetic and epigenetic alterations.	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.	Point in time blood collection (1 day) at enrollment.