Clinical trial NCT04027790: Plasma-based Colorectal Cancer Screening Research & Development
Official title: Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colo-rectal Cancer
Keywords: plasma
cell-free DNA
DNA Methylation
Lead sponsor: Epigenomics, Inc
Sponsor class: INDUSTRY
First posted: 2019-07-22
Enrollment: 354
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known colorectal cancer, prior to intervention (Group 1).

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Test Positivity
timeFrame: Anticipated time frame for testing blood sample is within 12 months of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: Epigenomics, Inc
name: Theo deVos, PhD
role: STUDY_DIRECTOR
References: