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

Completed

Conditions studied: Colorectal Cancer

In brief

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).

Key facts

Study ID

NCT03821948

Run by

Exact Sciences Corporation

People needed

5131

Starts

2019-01-03

Expected to finish

2020-05-15

Last updated by the study team

2020-07-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
• Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
• 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:
• Familial adenomatous polyposis (also referred to as "FAP").
• 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

Where it is running

• 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 — San Diego, California, 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
• Deaconess Clinic-Mt. Pleasant — Evansville, Indiana, United States
• Deaconess Clinic-Gateway — Newburgh, Indiana, United States
• New Orleans Research Institute — Metairie, Louisiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• Capitol Research — Rockville, Maryland, United States
• Great Lakes Medical Research, LLC — East Lansing, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• AGA Clinical Research Associates, LLC — Egg Harbor, New Jersey, United States
• Digestive Disease Care, PC — New Hyde Park, New York, United States
• Digestive Health Partners, PA — Asheville, North Carolina, United States
• Charlotte Gastroenterology and Hepatology, LLC — Charlotte, North Carolina, United States
• Trial Management Associates, LLC — Wilmington, North Carolina, United States
• Great Lakes Medical Research — Beachwood, Ohio, United States

Full record on ClinicalTrials.gov

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