Clinical trial NCT03706235: Colvera for Detection of Disease Recurrence
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Adenocarcinoma
Lead sponsor: Clinical Genomics Pathology
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value and negative predictive value
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Redondo Beach
country: United States
facility: Torrance Memorial Physician Network
state: California
city: Dover
country: United States
facility: Bayhealth
state: Delaware
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore Health System
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Metairie
country: United States
facility: Colon and Rectal Surgery Associates
state: Louisiana
city: Novi
country: United States
facility: Providence Hospital-Ascension Health
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute-Allina Health
state: Minnesota
city: Belleville
country: United States
facility: Essex Oncology
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: