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)

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

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
  • Age: 18 years - 100 years
  • 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.

Updated on 04 Aug 2024. Study ID: 1807394724

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