Colvera for Detection of Disease Recurrence

Colorectal Adenocarcinoma Clinical Trial

— NOVA  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706235
• Other study ID #: CG001
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: April 29, 2020

Study information

• Verified date: July 2020
• Source: Clinical Genomics Pathology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: April 29, 2020
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma
• Recurrence

Intervention

Other:
• Blood draw (venipuncture)
Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.

Locations

Country	Name	City	State
United States	Essex Oncology	Belleville	New Jersey
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospitals	Cleveland	Ohio
United States	Bayhealth	Dover	Delaware
United States	NorthShore Health System	Evanston	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Colon and Rectal Surgery Associates	Metairie	Louisiana
United States	Virginia Piper Cancer Institute-Allina Health	Minneapolis	Minnesota
United States	Providence Hospital-Ascension Health	Novi	Michigan
United States	Torrance Memorial Physician Network	Redondo Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Genomics Pathology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive predictive value and negative predictive value	on positive or negative Colvera and CEA test results	1.5 years