Department of Gastroenterology, Digestive Oncology Unit
Leuven, Belgium
NCT Number: NCT04920955
This is an observational case-control study which enroll metastatic and non-metastatic colorectal cancer (CRC) patients. The objective of this study is to evaluate a novel blood multi-marker test for the detection of relapse in colorectal cancer patients. This test is based on whole-blood transcriptomic signatures and circulating tumor methylated DNA markers. The patients will be enrolled into 4 study groups, two cross-sectional and two longitudinal groups, to follow up patients up to 36 months from primary tumor resection.
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Notify Me18 year and older
All sexes
Observational
Leuven, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Relapse occurring within 5 years from primary curative intervention
Sensitivity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method
Time frame: 36 months disease-free
Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method
Time frame: 24 months
Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points
Time frame: 24 months
Estimation of the multi-marker test positivity for all patients and time points
Time frame: 6 weeks
Intra- and inter-individual coefficient of variation of the biomarkers, pre- and post-surgery and during surveillance up to relapse
Time frame: up to 1 day prior to tumor resection
Sensitivity of the test for detection of primary CRC
Novigenix SA
Other
Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse
Acronym: RELMA-C
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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