An observational study in Colorectal Cancer, sponsored by Clinical Genomics Pathology. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Clinical Genomics Pathology · Observational
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 65 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Clinical Genomics Pathology is the lead sponsor of 2 studies on the registry; none are open to participants now.
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This prospective study will enroll 50 subjects with radiologic confirmation of recurrence of colorectal cancer and 50 subjects without CRC recurrence (documented by CT scan). Eligible study subjects will include men and women (18 years or older) of any race and ethnicity who have completed treatment (no further adjuvant chemotherapy or surgery currently planned) for primary CRC of stages II and III (AJCC, [2]), and have been considered by the site clinical management team for at least 6 months to be in remission. . (Concurrent imaging is not required as part of the clinical determination of remission. Subjects who have had a recent (within 4 weeks) or prior CT scan for purposes of surveillance are eligible.)
Exclusion Criteria:
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
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
20 ml of blood will be drawn from subjects via venipuncture
Sensitivity, specificity, positive predictive value and negative predictive value
Comparison of Colvera and CEA in recurrent and non-recurrent CRC
Time frame: 1 year
Plan to share: Yes — Data from each subject is captured without any identifiers in an electronic database.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Clinical Genomics Pathology