Plasma-based Colorectal Cancer Screening Research & Development

Epigenomics

Status: Completed

Conditions: Colo-rectal Cancer

Treatments: Diagnostic Test: Epi proColon

Study type: Observational

Funder types: Industry

Identifiers

NCT04027790

ECS0001

Details and patient eligibility

About

The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.

Full description

The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.

Enrollment: 354 patients

Sex: All

Ages: 45 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Group 1

• Willing and able to sign an Informed Consent and adhere to study requirements.

• Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality).

• Colonoscopy diagnosis of colorectal cancer (CRC).*

• Blood sampling a minimum of 7 days after colonoscopy and before resection surgery.

  • = Strong clinical suspicion of colorectal carcinoma is also acceptable for subject enrollment; Case must have a confirmed diagnosis after surgery of CRC and be accompanied by a complete final pathology report.

Inclusion Criteria: Group 2

• Willing and able to sign an Informed Consent and adhere to study requirements.
• Eligible for colorectal cancer screening colonoscopy.
• 45 - 84 years of age at blood sampling.
• Able to provide blood sample within up to 2 weeks prior to bowel prep and colonoscopy.

Exclusion Criteria: Group 1

• Subject with curative biopsy during colonoscopy.
• Current neoadjuvant treatment.
• Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
• Known infection with HIV, HBV or HCV.

Exclusion Criteria: Group 2

• Previous personal history of CRC, adenomatous polyps >10mm or sessile serrated adenomas (polyps).
• Familial risk for colorectal cancer (1 or more 1st degree relatives with CRC; known HNPCC or FAP).
• History of inflammatory bowel disease.
• Current neoadjuvant treatment.
• Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
• infection with HIV, HBV or HCV.

Trial design

354 participants in 2 patient groups

Group 1 - Cancer Patients

Description:

Subjects with known colorectal cancer (i.e. AJCC/UICC stages 0, I, II, and III) who provide plasma at least 7 days after diagnosis by colonoscopy, but prior to surgery or treatment

Treatment:

Diagnostic Test: Epi proColon

Group 2 - Screening Subjects

Description:

Prospectively enrolled subjects reporting for screening colonoscopy who provide a blood sample up to 2 weeks prior to bowel prep and prior to colonoscopy. We accept all subjects who meet the institutional criteria as average risk subjects referred for a screening colonoscopy for colorectal cancer, including subjects undergoing a colonoscopy as a follow-up to a positive (non-colonoscopic) test

Treatment:

Diagnostic Test: Epi proColon