A Multi-omics Study of BRAF V600E Mutant Colorectal Cancer

NCT07007689 | Not Yet Recruiting

• 1 other identifier: 2025ZSLYEC-156
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

BRAF V600E-mutant Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• prediction accuracy of treatment response

  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.

  through study completion, an average of 3 years

Secondary Outcomes (1)

• prediction of accuracy of survival rate

  through study completion, an average of 3 years

Study Arms (1)

BRAF V600E mutant colorectal cancer cohort

Single-cell RNA sequencing, TCR sequencing, proteomics and metabolomics of 200 prospectively collected tissue samples. TCR sequencing of 200 prospectively collected blood samples.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must meet all inclusion and exclusion criteria. In addition, the patient should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent should be obtained from the patient prior toenrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

You may qualify if:

• Written informed consent to study procedures;
• Men and women aged ≧18 years;
• Diagnosis of histologically or cytologically confirmed colorectal cancer;
• First-generation sequencing or next-generation sequencing at any time prior to screening confirms the presence of BRAF V600E mutation in tumor tissue.

You may not qualify if:

• Patients with serious heart disease, hypertension, cerebral hemorrhage or uncontrollable systemic diseases (such as: diabetes, hypertension, pulmonary fibrosis and acute pneumonia);
• Women who are pregnant or nursing;
• Unable to co-operate in sampling;
• Received more than two prior regimens of systemic cancer therapy for colorectal cancer.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Biospecimen

Retention: SAMPLES WITH DNA

The fresh tumor tissues/biopsies and peripheral blood samples of each patient will be collected.

Central Study Contacts

Yanhong Deng, M.D.

CONTACT

86-13925106525; dengyanh@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology, Clinical Professor

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share