NCT04027790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

June 6, 2019

Last Update Submit

February 1, 2021

Conditions

Colo-rectal Cancer

Keywords

plasmacell-free DNADNA Methylation

Outcome Measures

Primary Outcomes (1)

  • Test Positivity

    DNA methylation status of Epi proColon and biomarker panel

    Anticipated time frame for testing blood sample is within 12 months of collection

Study Arms (2)

Group 1 - Cancer Patients

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

Diagnostic Test: Epi proColon

Group 2 - Screening Subjects

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

Diagnostic Test: Epi proColon

Interventions

Epi proColonDIAGNOSTIC_TEST

Analysis of DNA methylation status for Septin9 and additional biomarkers

Group 1 - Cancer PatientsGroup 2 - Screening Subjects

Eligibility Criteria

Age45 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of South Florida

Tampa, Florida, 33606, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70170, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA plasma samples

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Theo deVos, PhD

    Epigenomics, Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

July 22, 2019

Study Start

May 3, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

US(5)