Plasma-based Colorectal Cancer Screening Research & Development

Colo-rectal Cancer Clinical Trial

Official title:

Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027790
• Other study ID #: ECS0001
• Status: Completed
• Start date: May 3, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2021
• Source: Epigenomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Epi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of Pennsylvania Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Springfield Clinic	Springfield	Illinois
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test Positivity	DNA methylation status of Epi proColon and biomarker panel	Anticipated time frame for testing blood sample is within 12 months of collection