Clinical trial NCT03741166: Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.
Official 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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colo-rectal Cancer
Keywords: Blood Draw
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 871
Sex: ALL
Minimum age (years): 45
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Up to 942 subjects will be enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood-based biomarkers associated with genetic and epigenetic alterations.
timeFrame: Point in time blood collection (1 day) at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Camarillo
country: United States
facility: Ventura County Gastroenterology
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Oxnard
country: United States
facility: Focilmed
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: New Haven
country: United States
facility: Yale University Section of Digestive Diseases and Liver Diseases
state: Connecticut
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Evanston
country: United States
facility: Northshore University Health System Evanston Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: DM Clinical Research- Southwest Gastroenterology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic- Mt. Pleasant
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic- Gateway
state: Indiana
city: Lenexa
country: United States
facility: Johnson County ClinTrials, LLC
state: Kansas
city: Metairie
country: United States
facility: New Orleans Research Institue
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Capitol Research
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Wooster
country: United States
facility: Comprehensive Internal Medicine, Inc.
state: Ohio
city: Wooster
country: United States
facility: Family Practice Center of Wooster, Inc./Clinical Trial Developers
state: Ohio
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center- McGovern Medical School
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- PCP for Life
state: Texas
city: Suffolk
country: United States
facility: Virginia Gastroenterology Institute
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Indiana University
name: Thomas Imperiale
role: PRINCIPAL_INVESTIGATOR
References: