Clinical trial · Observational
Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
- 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)
The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Thoroughness to report molecular profiling
- timeFrame
- 14 days from sample acquisition
- description
- Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition.
Secondary outcomes (2)
- measure
- Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC
- timeFrame
- 24 months from first patient in.
- description
- number of patients with detected genetic alteration included in the panel (mutations and/or copy number variations) over all recruited patients.
- measure
- Percentage of complete data capture for treatment-related check-point events
- timeFrame
- through study completion, an average of five years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery. * Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital. * Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year. * Age ≥18. * ECOG PS 0-1. * No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial. * Signed informed consent. Exclusion Criteria: * Symptomatic brain metastases. * Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption. * History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years. * No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
References
Publications (0)
Data not yet available