Breast NeoplasmsNCT06833723
Development of a Multi-omics Prediction Model for Immunotherapy Response in Triple-Negative Breast Cancer Subtypes
An observational study of Breast Neoplasms, run by Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Retrospective Data Collection and Analysis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2025to 17 Nov 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study Population Description: The study population consists of female breast cancer patients who received or are expected to receive immunotherapy/neoadjuvant immunotherapy at our institution. The study is divided into two cohorts: Retrospective Cohort (2015-2023): Includes patients who received immunotherapy/neoadjuvant immunotherapy between January 1, 2015, and September 30, 2023. Prospective Cohort (2023-Present): Includes patients who may receive immunotherapy/neoadjuvant immunotherapy starting from October 1, 2023. All participants are female, aged ≥ 18 years, and able to provide sufficient tumor tissue samples, blood samples, and imaging data.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
This research will utilize a comprehensive approach by analyzing various types of clinical samples from breast cancer patients treated with immunotherapy. The integration of proteomic, transcriptomic, and metabolomic data, along with advanced imaging techniques like IMC and spatial transcriptomics, will allow for a detailed understanding of the tumor microenvironment and its response to immunotherapy. This multi-dimensional analysis aims to enhance the accuracy of predicting immunotherapy outcomes, thereby aiding in personalized treatment strategies for breast cancer patients. The study adheres strictly to ethical guidelines, ensuring patient confidentiality and welfare are maintained throughout the research process.
- Conditions
- Breast Neoplasms
- Being tested
- Retrospective Data Collection and Analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Data Collection and AnalysisOther
This is a retrospective study involving the collection and analysis of existing clinical data from breast cancer patients who received immunotherapy or neoadjuvant immunotherapy between January 1, 2015, and September 30, 2023. No new interventions are administered as part of this study. The data includes diagnostic puncture tissue, residual tumor tissue post-surgery, blood samples, and imaging data. These samples are analyzed using multi-omics approaches (proteomics, transcriptomics, metabolomics) and advanced imaging techniques (imaging mass cytometry and spatial transcriptomics) to build a predictive model for immunotherapy efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort (2015-2023) | This group includes breast cancer patients who were treated at our institution from January 1, 2015, to September 30, 2023, and received immunotherapy or neoadjuvant immunotherapy. Clinical samples (e.g., fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data) from these patients will be retrospectively collected and analyzed. The data will be used to build and validate the predictive model for immunotherapy efficacy. Receives: Other: Retrospective Data Collection and Analysis | |
| Cohort (2023-Present) | This group includes breast cancer patients treated at our institution starting from October 1, 2023, who are potential candidates for immunotherapy or neoadjuvant immunotherapy. Clinical samples (e.g., fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data) will be prospectively collected. These samples will undergo multi-omics analysis (proteomics, transcriptomics, metabolomics) and advanced imaging techniques (imaging mass cytometry and spatial transcriptomics) to further refine and validate the predictive model for immunotherapy efficacy. Receives: Other: Retrospective Data Collection and Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Accuracy of Immunotherapy Efficacy Model
The primary outcome is the predictive accuracy of the multi-omics and multi-dimensional model in determining the efficacy of immunotherapy in breast cancer patients. The model will be evaluated based on its ability to correctly classify patients as responders or non-responders to immunotherapy using clinical outcomes (e.g., progression-free survival, overall survival) as the gold standard.
Measured: From the date of sample collection (retrospective cohort: 2015-2023; prospective cohort: 2023-present) until the end of follow-up (up to 5 years post-treatment).
Secondary outcomes (1)
Correlation Between Multi-Omics Profiles and Immunotherapy Response
To assess the relationship between proteomic, transcriptomic, and metabolomic profiles of tumor tissue and the clinical response to immunotherapy.
Measured: From the date of sample collection until the end of follow-up (up to 5 years post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start17 Apr 2025
- Primary completion17 Dec 2025
- Study completion17 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Wu, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Investigators
- Qin Wu, Principal investigator, Hangzhou Institute of Medicine (HIM), Chinese Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833723
- Sponsor's protocol ID
- HIM-1
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and privacy concerns, the individual participant data will not be shared outside the research team.
Publications
Dong H, Wang X, Zheng Y, Li J, Liu Z, Wang A, Shen Y, Wu D, Cui H. Mapping the rapid growth of multi-omics in tumor immunotherapy: Bibliometric evidence of technology convergence and paradigm shifts. Hum Vaccin Immunother. 2025 Dec;21(1):2493539. doi: 10.1080/21645515.2025.2493539. Epub 2025 Apr 24.
PubMed 40275437
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06833723
- Acronym / sponsor ID
- HIM-1
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hangzhou Institute of Medicine (HIM), Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Nov 2027 (estimated)
- First posted
- 19 Feb 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 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.
Detailed description
This research will utilize a comprehensive approach by analyzing various types of clinical samples from breast cancer patients treated with immunotherapy. The integration of proteomic, transcriptomic, and metabolomic data, along with advanced imaging techniques like IMC and spatial transcriptomics, will allow for a detailed understanding of the tumor microenvironment and its response to immunotherapy. This multi-dimensional analysis aims to enhance the accuracy of predicting immunotherapy outcomes, thereby aiding in personalized treatment strategies for breast cancer patients. The study adheres strictly to ethical guidelines, ensuring patient confidentiality and welfare are maintained throughout the research process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort (2015-2023) | – | Other: Retrospective Data Collection and AnalysisThis group includes breast cancer patients who were treated at our institution from January 1, 2015, to September 30, 2023, and received immunotherapy or neoadjuvant immunotherapy. Clinical samples (e.g., fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data) from these patients will be retrospectively collected and analyzed. The data will be used to build and validate the predictive model for immunotherapy efficacy. |
| Cohort (2023-Present) | – | Other: Retrospective Data Collection and AnalysisThis group includes breast cancer patients treated at our institution starting from October 1, 2023, who are potential candidates for immunotherapy or neoadjuvant immunotherapy. Clinical samples (e.g., fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data) will be prospectively collected. These samples will undergo multi-omics analysis (proteomics, transcriptomics, metabolomics) and advanced imaging techniques (imaging mass cytometry and spatial transcriptomics) to further refine and validate the predictive model for immunotherapy efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population Description: The study population consists of female breast cancer patients who received or are expected to receive immunotherapy/neoadjuvant immunotherapy at our institution. The study is divided into two cohorts: Retrospective Cohort (2015-2023): Includes patients who received immunotherapy/neoadjuvant immunotherapy between January 1, 2015, and September 30, 2023. Prospective Cohort (2023-Present): Includes patients who may receive immunotherapy/neoadjuvant immunotherapy starting from October 1, 2023. All participants are female, aged ≥ 18 years, and able to provide sufficient tumor tissue samples, blood samples, and imaging data.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Data Collection and AnalysisThis is a retrospective study involving the collection and analysis of existing clinical data from breast cancer patients who received immunotherapy or neoadjuvant immunotherapy between January 1, 2015, and September 30, 2023. No new interventions are administered as part of this study. The data includes diagnostic puncture tissue, residual tumor tissue post-surgery, blood samples, and imaging data. These samples are analyzed using multi-omics approaches (proteomics, transcriptomics, metabolomics) and advanced imaging techniques (imaging mass cytometry and spatial transcriptomics) to build a predictive model for immunotherapy efficacy. | Other | Cohort (2015-2023), Cohort (2023-Present) |
Primary outcome
Predictive Accuracy of Immunotherapy Efficacy Model
Time frame: From the date of sample collection (retrospective cohort: 2015-2023; prospective cohort: 2023-present) until the end of follow-up (up to 5 years post-treatment).
The primary outcome is the predictive accuracy of the multi-omics and multi-dimensional model in determining the efficacy of immunotherapy in breast cancer patients. The model will be evaluated based on its ability to correctly classify patients as responders or non-responders to immunotherapy using clinical outcomes (e.g., progression-free survival, overall survival) as the gold standard.
1 secondary outcome
Correlation Between Multi-Omics Profiles and Immunotherapy Response
Time frame: From the date of sample collection until the end of follow-up (up to 5 years post-treatment).
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 15 Jan 2026.
- Derived from this study: PubMed 40275437Dong H, Wang X, Zheng Y, Li J, Liu Z, Wang A, Shen Y, Wu D, Cui H. Mapping the rapid growth of multi-omics in tumor immunotherapy: Bibliometric evidence of technology convergence and paradigm shifts. Hum Vaccin Immunother. 2025 Dec;21(1):2493539. doi: 10.1080/21645515.2025.2493539. Epub 2025 Apr 24.
- Individual participant dataSharing planned: No. Due to ethical and privacy concerns, the individual participant data will not be shared outside the research team.
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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. This study is not recruiting at the moment.
Qin Wu principal investigator
Hangzhou Institute of Medicine (HIM), Chinese Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences at 1 site in China.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Accuracy of Immunotherapy Efficacy Model (time frame: From the date of sample collection (retrospective cohort: 2015-2023; prospective cohort: 2023-present) until the end of follow-up (up to 5 years post-treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06833723, which also lists 1 linked publication.
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 15 Jan 2026.