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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789162
• Other study ID #: 2018-07
• Status: Recruiting
• Start date: December 20, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Exact Sciences Corporation
• Contact: Amber Cheng
• Phone: 608.982.1588
• Email: acheng[@]exactsciences.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Canada	University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre	Calgary	Alberta
United States	Digestive Health Partners, PA	Asheville	North Carolina
United States	Clinical Trials Network	Beachwood	Ohio
United States	University Health Service Hospitals, Inc.	Binghamton	New York
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Susquehanna Research Group	Camp Hill	Pennsylvania
United States	Alliance Research Institute	Canoga Park	California
United States	Charlotte Gastroenterology & Hepatology, PLLC	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	GW Research Inc	Chula Vista	California
United States	Northside Gastroenterology Associates PA	Cypress	Texas
United States	Clinical Trials Network	East Lansing	Michigan
United States	Presque Isle Colon and Rectal Surgery, an affiliate of The Clinical Trials Network, LLC	Erie	Pennsylvania
United States	Deaconess Clinic, Inc	Evansville	Indiana
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Gastroenterology Associates of Fairfield County, P.C.	Fairfield	Connecticut
United States	Gastro One	Germantown	Tennessee
United States	HSHS St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Connecticut Clinical Research Institute	Hartford	Connecticut
United States	Digestive Health Research, LLC	Hermitage	Tennessee
United States	Digestive Health	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	The Jackson Clinic Professional Association	Jackson	Tennessee
United States	Tilda Research	Laguna Hills	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Virtua Health Inc	Marlton	New Jersey
United States	Clinical Trials Network	Mentor	Ohio
United States	MZS Research, LLC	Metairie	Louisiana
United States	Delta Research Partners	Monroe	Louisiana
United States	Clinical Trials of America, LLC	Mount Airy	North Carolina
United States	Yale University	New Haven	Connecticut
United States	Digestive Disease Care, PC	New Hyde Park	New York
United States	Icahn School of Medicine at Mount Sinai Beth Israel	New York	New York
United States	DM Clinical Research/Southwest Gastroenterology	Oak Lawn	Illinois
United States	Mayo Clinic - Arizona	Phoenix	Arizona
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	Clinical Trials Network	San Diego	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Digestive Research Alliance of Michiana, LLC	South Bend	Indiana
United States	Spartanburg Regional Health Services District, Inc	Spartanburg	South Carolina
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Virginia Gastroenterology Institute	Suffolk	Virginia
United States	MultiCare Institute for Research & Innovation - Tacoma	Tacoma	Washington
United States	Guardian Angel Research Center	Tampa	Florida
United States	Texarkana Clinical Research	Texarkana	Texas
United States	Advanced Gastroenterology	Union City	Tennessee
United States	Frontier Clinical Research, LLC	Uniontown	Pennsylvania
United States	Carle Foundation Hospital dba Carle Cancer Center	Urbana	Illinois
United States	Clinical Trials of America, LLC	West Monroe	Louisiana
United States	Clinical Trials Network	Westlake	Ohio
United States	Trial Management Associates, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool-based biomarkers associated with genetic and epigenetic alterations	The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.	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
Primary	Blood-based biomarkers associated with genetic and epigenetic alterations	The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.	Point in time blood collection (1 day) at enrollment