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Colvera for Detection of Disease Recurrence (NOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706235
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Clinical Genomics Pathology

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.

Condition or disease Intervention/treatment
Colorectal Adenocarcinoma 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.

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Study Type : Observational
Actual Enrollment : 488 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 16, 2019
Actual Study Completion Date : April 29, 2020

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.




Primary Outcome Measures :
  1. Sensitivity, specificity, positive predictive value and negative predictive value [ Time Frame: 1.5 years ]
    on positive or negative Colvera and CEA test results


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706235


Locations
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United States, California
Torrance Memorial Physician Network
Redondo Beach, California, United States, 90277
United States, Delaware
Bayhealth
Dover, Delaware, United States, 19901
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
NorthShore Health System
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Colon and Rectal Surgery Associates
Metairie, Louisiana, United States, 70001
United States, Michigan
Providence Hospital-Ascension Health
Novi, Michigan, United States, 48374
United States, Minnesota
Virginia Piper Cancer Institute-Allina Health
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Essex Oncology
Belleville, New Jersey, United States, 07109
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
University Hospitals
Cleveland, Ohio, United States, 44106
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Clinical Genomics Pathology
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Responsible Party: Clinical Genomics Pathology
ClinicalTrials.gov Identifier: NCT03706235    
Other Study ID Numbers: CG001
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes