NCT06833723Active, not recruiting
Development of a Multi-omics Prediction Model for Immunotherapy Response in Triple-Negative Breast Cancer Subtypes
Construction and Validation of a Multi-omics Prediction Model to Assess Immunotherapy Efficacy in Patients With Triple-Negative Breast Cancer Subtypes Based on Genomic, Transcriptomic, Proteomic, and Immune Profiling Data
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
This study aims to collect clinical samples from breast cancer patients who have undergone or are expected to undergo immunotherapy at our institution. The samples, including fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data, will be used to build a predictive model for immunotherapy efficacy. The research will employ proteomics, transcriptomics, metabolomics sequencing, imaging mass cytometry (IMC), and spatial transcriptomics to construct a multi-omics, multi-dimensional (temporal and spatial) model to predict the effectiveness of immunotherapy.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 13 Feb 2025
- Start date
- 17 Apr 2025
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06833723
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 17 Apr 2025 to the primary completion date, 17 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Male breast cancer patients.
- Inability to provide sufficient tumor tissue samples or other clinical data.
- Presence of severe comorbidities (e.g., active infections, severe cardiac, hepatic, or renal dysfunction) that may affect the safety assessment of immunotherapy.
- Lack of signed informed consent (for the prospective cohort).
Who the study is looking for
- \- Female, aged ≥ 18 years.
- Pathologically confirmed diagnosis of breast cancer.
- Patients who received immunotherapy/neoadjuvant immunotherapy at our institution between January 1, 2015, and September 30, 2023 (retrospective cohort), or patients who may receive immunotherapy/neoadjuvant immunotherapy starting from October 1, 2023 (prospective cohort).
- Availability of sufficient tumor tissue samples (e.g., fresh biopsy tissue, residual tumor tissue post-surgery).
- Availability of blood samples and imaging data.
- Signed informed consent (for the prospective cohort).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.