Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast

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 the detection of colorectal cancer (CRC).

Key facts

Study ID

NCT03789162

Run by

Exact Sciences Corporation

People needed

850

Starts

2018-12-20

Expected to finish

2025-05-29

Last updated by the study team

2025-06-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is 40 years of age or older.
• Participant has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CT colonography.
• Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
• Participant understands the study procedures and is able to provide informed consent to take part 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.
• Less than 7 days between colonoscopy and blood and/or stool specimen collection.
• IV contrast (e.g., CT or MRI) within 1 day [or 24 hours] before blood and/or stool collection.
• Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.

Where it is running

• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• Alliance Research Institute — Canoga Park, California, United States
• GW Research Inc — Chula Vista, California, United States
• Tilda Research — Laguna Hills, California, United States
• Clinical Trials Network — San Diego, California, United States
• Gastroenterology Associates of Fairfield County, P.C. — Fairfield, Connecticut, United States
• Connecticut Clinical Research Institute — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Guardian Angel Research Center — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• DM Clinical Research/Southwest Gastroenterology — Oak Lawn, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Carle Foundation Hospital dba Carle Cancer Center — Urbana, Illinois, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Digestive Research Alliance of Michiana, LLC — South Bend, Indiana, United States
• MZS Research, LLC — Metairie, Louisiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Clinical Trials of America, LLC — West Monroe, Louisiana, United States
• Capitol Research — Rockville, Maryland, United States
• HealthPartners Institute — Saint Louis Park, Minnesota, United States
• Park Nicollet Oncology Research — Saint Louis Park, Minnesota, United States
• Virtua Health Inc — Marlton, New Jersey, United States
• University Health Service Hospitals, Inc. — Binghamton, New York, United States
• Icahn School of Medicine at Mount Sinai Beth Israel — New York, New York, United States

Full record on ClinicalTrials.gov

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