Clinical trial NCT03821948: Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
Official title: Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Blood Draw
Sample Collection
Stool DNA
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 5131
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

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