This study is currently not recruiting participants.

Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed with Colorectal Cancer

Study on Blood Tests for Detecting Recurrent Colorectal Cancer

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

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. The primary objective is to compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in colorectal cancer subjects who are undergoing surveillance for recurrence.

Detailed description of study

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. The primary objective is to compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in colorectal cancer subjects who are undergoing surveillance for recurrence.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: colorectal cancer
  • Age: 100 years or below
  • Gender: All

This study investigates the use of blood tests to detect recurring colorectal cancer in patients who have completed treatment. Colorectal cancer, or CRC, affects the colon or rectum and can be treated if caught early. This study focuses on patients who had stage II or III CRC, which means the cancer had spread to nearby tissues but not to distant parts of the body. These patients are now in remission, meaning there are no signs of cancer after treatment, and they are undergoing regular check-ups to monitor for any return of the disease.

In this study, researchers collect blood samples from participants to test for certain DNA markers and a protein called CEA. CEA stands for carcinoembryonic antigen, which can be a sign of cancer when found in high amounts. The study compares two tests: one that looks for specific DNA changes linked to cancer and the CEA test. By comparing these tests, researchers hope to find out which is better at detecting cancer that has come back.

  • Who can participate: Participants must have completed treatment for stage II or III colorectal cancer and be in remission. They should be scheduled for follow-up imaging as part of their routine check-ups. Participants aged 18 and older are eligible.
  • Study details: Participants will provide blood samples for testing. These samples will be analyzed for specific DNA markers and CEA levels. CEA is a protein that can indicate cancer presence. No treatment is given; this study is purely observational.
Updated on 19 Feb 2024. Study ID: 1712305918 (SURG-CLINGEN-

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