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A Retrospective-Prospective observational study in China to describe the management in clinical practice of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation who have received prior systemic therapy

A Retrospective-Prospective observational study in China to describe the management in clinical practice of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation who have received prior systemic therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065134
Enrollment
Unknown
Registered
2022-10-28
Start date
2021-12-31
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic colorectal cancer

Interventions

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age=18 years at the time of enrollment for the prospective cohort or at the time of 2nd line treatment for the retrospective cohort; 2. Histologically or cystologically confirmed diagnosis of recurrent/metastatic colorectal cancer previously treated with 1 or 2 systemic therapy(ies); 3. Genetic testing report confirming the presence of BRAF V600E mutation in tumor tissues; 4. Understand the content of the trial protocol and sign the informed consent form (ICF can be waived under the Ethics Committee agreement).

Exclusion criteria

Exclusion criteria: 1. The diagnosis of colorectal cancer is accompanied by other major cancers; 2. Participated in clinical trials of other intervention drugs during 1st or 2nd line treatment; 3. The patient or his family members do not agree to participate in this study; 4. ls participating in other clinical trials; 5. According to the judgment of the investigator, there are other conditions that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Describe the treatment path of the target population;

Secondary

MeasureTime frame
The therapeutic effect was evaluated by disease progression, including overall survival , progression free survival and objective remission rate;Demographic information and clinical characteristics of the target population were described;Describe the major adverse effects of treatment (CTCAE levels 2-5, AE/SAE/irAE);EQ5D scale was used to evaluate the progress of quality of life of the target population;Describe patients' expenditure on healthcare resource use from a whole-society perspective;

Countries

China

Contacts

Public ContactKefeng Ding
dingkefeng@zju.edu.cn13906504783

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026