BRAF V600E-mutant Metastatic Colorectal CancerNCT07007689
A Multi-omics Study of BRAF V600E Mutant Colorectal Cancer
An observational study of BRAF V600E-mutant Metastatic Colorectal Cancer, run by Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF V600E-mutant Metastatic Colorectal Cancer
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
As an oncogenic gene, BRAF V600E subverts the need for continuous upstream activation and overcomes negative feedback signals that terminate pathway activation. In colorectal cancer, BRAF V600E mutations are associated with older age, right colon primary tumors and female gender, as well as reduced chemotherapy sensitivity and poor prognosis. In addition to a poor prognosis, BRAF V600E-mutant colorectal cancer is associated with a higher incidence of peritoneal metastasis, resulting in tumor-related symptoms such as pain, ascites, gastrointestinal and urinary obstruction, which severely compromise patients' quality of life. Although there is a trend that BRAF V600E mutant patients who receive high-intensity chemotherapy have longer progression-free survival (PFS), the prognosis of the BRAF V600E mutant population remains dismal and approximately 40% of patients do not respond to first-line high-intensity chemotherapy. In addition, the response rate of combined targeted therapy is limited to around 25% and the duration of anti-epidermal growth factor receptor (EGFR) and anti-BRAF is around 4 months due to the presence of bypass activation. What's more, patients with BRAF V600E mutation and mismatch repair-proficient (pMMR) also had a poor response to anti-programmed death-1 (PD-1) therapy. The tumor heterogeneity and tumour immune microenvironment of BRAF V600E mutant colorectal cancer need to be investigated. 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
prediction of accuracy of survival rate
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.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAF V600E-mutant Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007689
- Sponsor's protocol ID
- 2025ZSLYEC-156
- Status last verified
- Jun 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Study of BRAF V600E Mutant Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07007689
- Acronym / sponsor ID
- 2025ZSLYEC-156
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As an oncogenic gene, BRAF V600E subverts the need for continuous upstream activation and overcomes negative feedback signals that terminate pathway activation. In colorectal cancer, BRAF V600E mutations are associated with older age, right colon primary tumors and female gender, as well as reduced chemotherapy sensitivity and poor prognosis. In addition to a poor prognosis, BRAF V600E-mutant colorectal cancer is associated with a higher incidence of peritoneal metastasis, resulting in tumor-related symptoms such as pain, ascites, gastrointestinal and urinary obstruction, which severely compromise patients' quality of life. Although there is a trend that BRAF V600E mutant patients who receive high-intensity chemotherapy have longer progression-free survival (PFS), the prognosis of the BRAF V600E mutant population remains dismal and approximately 40% of patients do not respond to first-line high-intensity chemotherapy. In addition, the response rate of combined targeted therapy is limited to around 25% and the duration of anti-epidermal growth factor receptor (EGFR) and anti-BRAF is around 4 months due to the presence of bypass activation. What's more, patients with BRAF V600E mutation and mismatch repair-proficient (pMMR) also had a poor response to anti-programmed death-1 (PD-1) therapy. The tumor heterogeneity and tumour immune microenvironment of BRAF V600E mutant colorectal cancer need to be investigated. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prediction accuracy of treatment response
Time frame: through study completion, an average of 3 years
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.
1 secondary outcome
prediction of accuracy of survival rate
Time frame: through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of BRAF V600E-mutant Metastatic Colorectal Cancer, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Deng, M.D. (86-13925106525, dengyanh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction accuracy of treatment response (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.