Paired Analysis of Sensitivity for Colorectal Cancer Using COLVERA : PASCAL

Study Overview
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Brief Summary
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To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in subjects with colorectal cancer that have documented recurrence or no evidence of recurrence by CT.

Detailed Description
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The study will be carried out as a single cohort, observational, prospective study to compare sensitivity of Colvera to detect recurrent colorectal cancer confirmed by radiology imaging (CT) with CEA sensitivity in paired testing. 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 (No evidence of disease). Subjects will have recently (within 4 weeks of blood collection) had 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 PAXgene blood tubes (minimum 10 mL, maximum 20 mL) 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.

Official Title
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Evaluation of the Performance and Sensitivity of the Clinical Genomics Colvera Test in Predicting Recurrence of Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Blood Draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 was determined to be in remission at the conclusion of primary therapy and has been in clinical surveillance for at least 6 months. (No imaging is required for the determination of remission. Last treatment was at least 6 months earlier. No requirement to complete all of the initial adjuvant treatment plan.) Subject has had a surveillance CT scan within the past 4 weeks and either has recurrent CRC or does not have recurrent CRC based on that CT scan result. Subject is willing to provide a blood sample. (2 PAXgene tubes) Definition of recurrence is evidence of local tumor recurrence or metastasis by CT scan of chest, abdomen and pelvis or other modalities that confirm recurrent CRC Exclusion Criteria: Subject has other cancer at the time of recruitment. Subject has prior history of recurrent CRC. Subject has a diagnosis of End Stage Renal Disease (ESRD), with or without current dialysis treatment. Subject's life expectancy is less than one year based on performance status and clinical signs and symptoms. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between radiological imaging and blood collection. Results of the recent surveillance CT of the chest, abdomen and pelvis are inconclusive regarding recurrence of CRC, and further work up (other imaging and/or biopsy) is not required at this time.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No recurrence<br>CT scan has confirmed that subjects are without recurrence. Blood can be drawn up to 4 weeks after scan. Effective Feb 28, 2019, this group is closed to accrual as it has reached the goal. | Other: Blood Draw<br>* 20 ml of blood will be drawn from subjects via venipuncture<br>|
| Recurrence<br>CT scan has confirmed that subjects are have recurrence of their colorectal cancer. Blood can be drawn prior to any treatment for the recurrent disease. | Other: Blood Draw<br>* 20 ml of blood will be drawn from subjects via venipuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive predictive value and negative predictive value | Comparison of Colvera and CEA in recurrent and non-recurrent CRC | 1 year |