Clinical trial · Observational
A Retrospective Study Project of Clinico-molecular Characterization in Patients With Metastatic Colorectal Cancer
A Proof-of-concept Study Investigating the Comparison of the RAS Mutational Status Between Primary Tumor and Metastasis in Patients Affected by Metastatic Colorectal Cancer on the Basis of Different Chemotherapeutic Regimens
NCT04338542CI-TRIAL-00046560completedClinicalTrials.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 a retrospective, translational, proof-of-concept study on tumor biopsies done on patients affected by mCRC and exhibiting RAS mutation. For each patient it will be selected the tissue biopsies of primary tumour and of paired resected metastasis.
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 |
|---|---|---|---|
| Mestastatic ColoRectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor biobsies analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- neoadjuvant chemotherapy plus bevacizumab
- description
- Patients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, finally, the surgical resection of liver metastasis.
- interventionNames
- Genetic: Tumor biobsies analysis
- label
- neoadjuvant chemotherapy
- description
- Patients treated with surgery of the primary tumor, neoadjuvant chemotherapy and, finally, the surgical resection of liver metastasis.
- interventionNames
- Genetic: Tumor biobsies analysis
- label
- control group
- description
- Patients presenting with synchronous primary tumour and metastasis resected without any preoperative systemic therapy.
- interventionNames
- Genetic: Tumor biobsies analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
General inclusion criteria (valid for all the three cohorts): * patients with biopsy-proven, stage IV CRC; * RAS mutation at diagnosis; * availability of tissue biopsy/resection of both primary tumour and paired liver metastasis for the molecular characterization; General exclusion criteria (valid for all the three cohorts): * inadequate material for the molecular characterization of the primary tumour and/or of the related metastasis; * insufficient amount (%) of tumour cells; Specific inclusion criteria for each group: 1. st group: * first-line bevacizumab plus chemotherapy before resection of liver metastases; * metastases must be resected metachronously with respect to the primary tumor. 2. nd group: * first-line chemotherapy without bevacizumab before resection of liver metastases; * metastases must be resected metachronously with respect to the primary tumor. 3. rd group: * no systemic therapy (immediate surgical resection of primary tumor and paired liver metastases); * primary tumour and metastasis can be synchronous or metachronous.
References
Publications (0)
Data not yet available
No reference posted for this study.