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"
1 other identifier
observational
488
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2020
CompletedJuly 14, 2020
July 1, 2020
1.5 years
October 11, 2018
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity, specificity, positive predictive value and negative predictive value
on positive or negative Colvera and CEA test results
1.5 years
Study Arms (2)
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.
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.
Interventions
Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.
Eligibility Criteria
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.
You may qualify if:
- Subject is 18 years or older, and capable and willing to provide informed consent.
- Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).
- Subject has no clinical evidence of disease (NED) (after initial treatment)
- Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy)
- Subject is willing/able to provide a blood sample
You may not qualify if:
- Subject has evidence of residual disease.
- Subject has other organ cancer at the time of recruitment.
- Subject has prior history of recurrent CRC.
- Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate.
- Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Torrance Memorial Physician Network
Redondo Beach, California, 90277, United States
Bayhealth
Dover, Delaware, 19901, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore Health System
Evanston, Illinois, 60201, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Colon and Rectal Surgery Associates
Metairie, Louisiana, 70001, United States
Providence Hospital-Ascension Health
Novi, Michigan, 48374, United States
Virginia Piper Cancer Institute-Allina Health
Minneapolis, Minnesota, 55407, United States
Essex Oncology
Belleville, New Jersey, 07109, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Biospecimen
Plasma samples are used to isolate cf DNA for identification of methylated markers. Leftover plasma with or without extracted DNA may be kept to repeat assays.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 15, 2018
Study Start
February 1, 2018
Primary Completion
August 16, 2019
Study Completion
April 29, 2020
Last Updated
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
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.