Clinical trial NCT03789162: Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
Official title: Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Blood Draw
Sample Collection
Stool DNA
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1500 subjects will be enrolled. Participants will be 40 years of age or older, with 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 computed tomography (CT) colonography.

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 the detection of colorectal cancer (CRC).

Detailed description: Participants will be 40 years of age or older, with 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 computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.

Eligibility criteria: Inclusion Criteria:

1. Participant is 40 years of age or older.
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

1. 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.
2. Less than 7 days between colonoscopy and blood and/or stool specimen collection.
3. IV contrast (e.g., CT or MRI) within 1 day \[or 24 hours\] before blood and/or stool collection.
4. Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.

Primary outcomes:
measure: Stool-based biomarkers associated with genetic and epigenetic alterations
timeFrame: Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure
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: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Chula Vista
country: United States
facility: GW Research Inc
state: California
city: Laguna Hills
country: United States
facility: Tilda Research
state: California
city: San Diego
country: United States
facility: Clinical Trials Network
state: California
city: Fairfield
country: United States
facility: Gastroenterology Associates of Fairfield County, P.C.
state: Connecticut
city: Hartford
country: United States
facility: Connecticut Clinical Research Institute
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: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: DM Clinical Research/Southwest Gastroenterology
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital dba Carle Cancer Center
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: South Bend
country: United States
facility: Digestive Research Alliance of Michiana, LLC
state: Indiana
city: Metairie
country: United States
facility: MZS Research, LLC
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: West Monroe
country: United States
facility: Clinical Trials of America, LLC
state: Louisiana
city: Rockville
country: United States
facility: Capitol Research
state: Maryland
city: Saint Louis Park
country: United States
facility: HealthPartners Institute
state: Minnesota
city: St. Louis Park
country: United States
facility: Park Nicollet Oncology Research
state: Minnesota
city: Marlton
country: United States
facility: Virtua Health Inc
state: New Jersey
city: Binghamtom
country: United States
facility: University Health Service Hospitals, Inc.
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Beth Israel
state: New York
city: Asheville
country: United States
facility: Digestive Health Partners, PA
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Beachwood
country: United States
facility: Clinical Trials Network
state: Ohio
city: Mentor
country: United States
facility: Clinical Trials Network
state: Ohio
city: Camp Hill
country: United States
facility: Susquehanna Research Group
state: Pennsylvania
city: Uniontown
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Health Services District, Inc
state: South Carolina
city: Hermitage
country: United States
facility: Digestive Health Research, LLC
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic Professional Association
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology
state: Tennessee
city: Cypress
country: United States
facility: Northside Gastroenterology Associates PA
state: Texas
city: Houston
country: United States
facility: Digestive Health
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Texarkana
country: United States
facility: Texarkana Clinical Research
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: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation - Tacoma
state: Washington
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital Regional Cancer Center
state: Wisconsin
city: Calgary
country: Canada
facility: University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
state: Alberta
Study officials:
References: