Clinical trial · Observational
A Multi-omics Study of BRAF V600E Mutant Colorectal Cancer
- 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 trial aims to elucidate the immune landscape and genetic basis of BRAF-mutant colorectal cancer (CRC) in Chinese patients by analyzing tumor tissue and peripheral blood. Single-cell RNA sequencing, T cell receptor (TCR) sequencing, proteomics and metabolomics, will be performed on tumor tissues, alongside TCR sequencing of peripheral blood, to establish a comprehensive immune and genetic profile of BRAF-mutant CRC. The study seeks to identify novel immune biomarkers, therapeutic targets, and signaling pathways, and to enable molecular subtyping for precision treatment and personalized management of BRAF-mutant CRC patients.
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 |
|---|---|---|---|
| BRAF V600E-mutant Metastatic Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- BRAF V600E mutant colorectal cancer cohort
- description
- Single-cell RNA sequencing, TCR sequencing, proteomics and metabolomics of 200 prospectively collected tissue samples. TCR sequencing of 200 prospectively collected blood samples.
Primary outcomes (1)
- measure
- prediction accuracy of treatment response
- timeFrame
- through study completion, an average of 3 years
- description
- We will use gene data and treatment response data of the patients to construct a prediction model, the accuracy of model to anticipating partial response of patients is the primary.
Secondary outcomes (1)
- measure
- prediction of accuracy of survival rate
- timeFrame
- through study completion, an average of 3 years
- description
- We will use the gene data and follow-up data of the patients to construct a prediction model, the accuracy of model to anticipating the 3-year survival rate of patients is the secondary endpoint.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent to study procedures; 2. Men and women aged ≧18 years; 3. Diagnosis of histologically or cytologically confirmed colorectal cancer; 4. First-generation sequencing or next-generation sequencing at any time prior to screening confirms the presence of BRAF V600E mutation in tumor tissue. Exclusion Criteria: 1. Patients with serious heart disease, hypertension, cerebral hemorrhage or uncontrollable systemic diseases (such as: diabetes, hypertension, pulmonary fibrosis and acute pneumonia); 2. Women who are pregnant or nursing; 3. Unable to co-operate in sampling; 4. Received more than two prior regimens of systemic cancer therapy for colorectal cancer.
References
Publications (0)
Data not yet available