Evaluation of the Performance and Sensitivity of the Clinical Genomics Colvera Test in Predicting Recurrence of Colorectal Cancer (Paired Analysis of Sensitivity for Colorectal Cancer using COLVERA: PASCAL)
Colorectal Cancer: Blood Tests for Recurrence Detection
Brief description of study.
The purpose of this study is 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 of study
This is a single cohort observational, prospective comparison study where blood is collected for assay of methylated BCAT1 and IKZF1 DNA (?Colvera?), and for CEA assay, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC), and who are in remission and have had clinical follow-up (usually radiological imaging) as part of their surveillance program for recurrence. For each study subject, the Colvera and CEA test results will be judged as true or false with respect to the Reference Standard.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: colorectal cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Has undergone curative treatment for primary CRC of stages II and III (AJCC)
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.)
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 resul
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
Has other cancer at the time of recruitment
Has prior history of recurrent CRC
Has a diagnosis of End Stage Renal Disease (ESRD), with or without current dialysis treatment
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.
This study investigates the use of blood tests to detect the return of colorectal cancer. Colorectal cancer, or CRC, is a type of cancer that affects the colon or rectum. The study compares two tests: Colvera, which looks for specific DNA changes in the blood, and the CEA test, which measures a protein often found in higher levels in cancer patients. The goal is to see which test is better at identifying if the cancer has come back in patients who have already been treated for CRC and are in remission, meaning their cancer is not currently active.
Participants in the study will have their blood drawn to check for certain DNA changes and protein levels. These results will be compared to a standard reference to determine their accuracy. This study does not involve any new treatments or medications, but rather focuses on analyzing blood samples to evaluate the effectiveness of these tests in monitoring cancer recurrence.
- Who can participate: Adults who have been treated for stage II or III colorectal cancer and are currently in remission can participate. They must have had a CT scan in the last four weeks showing whether or not their cancer has returned. Participants must be willing to provide a blood sample.
- Study details: Participants will provide a blood sample to test for DNA changes and protein levels related to colorectal cancer. No treatments or medications are involved in this study, only blood sample collection for test comparison.
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