Clinical trial · Observational
Relapse Markers for Colorectal Cancer
Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse
NCT04920955CI-TRIAL-00075191RELMA-CcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- G1, CRC Relapse
- description
- Patients with an actual relapse of CRC, within 5 years from primary surgery. A single blood sample is collected at relapse diagnosis.
- label
- G2, CRC Disease-free
- description
- Patients previously diagnosed with CRC and declared disease-free for at least 36 months but less than 5 years. A single blood sample is collected at standard monitoring visit.
- label
- G3, CRC Disease-free (longitudinal)
- description
- Patients declared disease-free for at least 3 months but less than 18 months. Longitudinal blood samples will be collected during standard monitoring visits up to relapse, or for a maximum of 4 time points.
- label
- G4, Primary CRC (longitudinal)
- description
- Patients with an actual diagnosis of CRC who are eligible for a treatment with curative intent. Blood samples will be collected pre and post-surgery (\~6 weeks) and, eventually, at relapse.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.