Colvera for Detection of Disease Recurrence (NOVA)

Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"

To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.

Study Overview

• Status: Completed
• Conditions: Colorectal Adenocarcinoma
• Intervention / Treatment: Other: Blood draw (venipuncture)

Detailed Description

This is an observational, prospective comparison study, where blood is collected for assay of methylated BCAT1 and IKZF1 DNA and CEA, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC) and who are in remission and scheduled for follow-up radiological imaging as part of their surveillance program for recurrence. Participation is for one visit only as part of each subject's surveillance-monitoring schedule. Two K2-EDTA blood tubes and two PAXgene™ tubes will be collected Any evidence of methylated BCAT1 and/or IKZF1 DNA in blood represents a Colvera "positive" result. CEA levels of 5ug/L or higher will represent a "positive" result. Sensitivity and specificity of the Colvera and CEA test will be estimated and compared in a paired fashion in each case where recurrence status has been investigated and determined by the site clinical management team. Blood testing shall be performed and analyzed by qualified staff blinded to clinical status. This is a cross-sectional observational non-significant risk study, and test results will not be used for clinical management, i.e. there will be no interventions in subjects consenting to participate in this Research Study.

• Study Type: Observational
• Enrollment (Actual): 488

Contacts and Locations

Study Locations

• United States
  • California
    • Redondo Beach, California, United States, 90277
      • Torrance Memorial Physician Network
  • Delaware
    • Dover, Delaware, United States, 19901
      • Bayhealth
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Evanston, Illinois, United States, 60201
      • NorthShore Health System
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Colon and Rectal Surgery Associates
  • Michigan
    • Novi, Michigan, United States, 48374
      • Providence Hospital-Ascension Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute-Allina Health
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Essex Oncology
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects who have undergone curative treatment for primary Colon or rectal cancer of stages II and III (AJCC), and who are in remission and scheduled for clinical follow-up (usually radiological imaging) as part of their surveillance program for recurrence.

Description

Inclusion Criteria:

1. Subject is 18 years or older, and capable and willing to provide informed consent.
2. Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).
3. Subject has no clinical evidence of disease (NED) (after initial treatment)
4. Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy)
5. Subject is willing/able to provide a blood sample

Exclusion Criteria:

1. Subject has evidence of residual disease.
2. Subject has other organ cancer at the time of recruitment.
3. Subject has prior history of recurrent CRC.
4. Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate.
5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No recurrence; Subjects at least 30 days from end of primary treatment for colorectal cancer in a clinically indicated surveillance program (e.g. ASCO, NCCN) provide a blood sample before the next clinically indicated surveillance scan/imaging. Imaging documents no recurrence.	Other: Blood draw (venipuncture); Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.
Recurrence; Subjects at least 30 days from end of primary treatment for colorectal cancer in a clinically indicated surveillance program (e.g. ASCO, NCCN) provide a blood sample before the next clinically indicated surveillance scan/imaging or imaging has confirmed recurrence. Imaging documents recurrence.	Other: Blood draw (venipuncture); Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity, positive predictive value and negative predictive value	on positive or negative Colvera and CEA test results	1.5 years

Collaborators and Investigators

• Sponsor: Clinical Genomics Pathology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): August 16, 2019
• Study Completion (Actual): April 29, 2020

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: CG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data collected by recruiting sites is captured without any PHI or identifiers in an Electronic Data Capture system managed for the sponsor by a CRO.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No