Colorectal Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Novigenix SA
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years of age at time of informed consent. * Subject has signed the informed consent form (ICF) and is able to understand the information provided in it. * At least a blood sample is collected per subject according to the sample collection protocol. * Patients enrolled in local prospective protocols, in which samples have been collected according the study procedures may be included. * Group 1: patients with a radiologically and, whenever is possible, histologically confirmed relapse (local or distant) of colorectal cancer within 5 years from primary surgery. Metachronous primary tumors are not considered as relapse and should be excluded. * Group 2: Patients declared disease-free for at least 36 months but less than 5 years, as confirmed by radiological examination. * Group 3: Patients with a stage III-IV colorectal cancer with a curative treatment and disease-free for at least 3 months but less than 18 months. * Group 4: Histologically and radiologically confirmed diagnosis of stage I, II, III or IV colorectal adenocarcinoma, eligible for a treatment with curative intent.
Exclusion criteria
* Personal history of cancer (non-hematologic) other than CRC in complete remission for less than 5 years. * Personal history of hematologic cancer. * A blood transfusion within 6 weeks prior to inclusion into the study. * Transplant with regular intake of immunosuppressants. * Pregnant woman (self-declaration). * Conditions or comorbidities that would preclude the compliance with the planned surveillance program or with the protocol as judged by the Investigator. * Previous inclusion in the RELMA-C study and/or re-inclusion in a different study group. * Group 1: Any treatment for CRC relapse prior to blood collection. * Group 2: Patient is disease-free for less than 36 months or more than 5 years. * Group 3: Patient is disease-free for less than 3 months or more than 18 months * Group 3: Stage IV patients with detectable residual disease after primary treatment. * Group 4: Any cancer treatment prior to blood collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for relapse detection | 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 |
| Specificity for relapse detection | 36 months disease-free | Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance analyses | 24 months | Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points |
| Test positivity | 24 months | Estimation of the multi-marker test positivity for all patients and time points |
| Coefficient of variation of the biomarkers | 6 weeks | Intra- and inter-individual coefficient of variation of the biomarkers, pre- and post-surgery and during surveillance up to relapse |
| Sensitivity for CRC detection | up to 1 day prior to tumor resection | Sensitivity of the test for detection of primary CRC |
Countries
Belgium
Outcome results
None listed