Development of a Multi-omics Prediction Model for Immunotherapy Response in Triple-Negative Breast Cancer Subtypes

NCT06833723 | Active Not Recruiting

• 1 other identifier: HIM-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From the date of sample collection until the end of follow-up (up to 5 years post-treatment).

Study Arms (2)

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.

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.

Other: Retrospective Data Collection and Analysis

Interventions

Retrospective Data Collection and Analysis OTHER

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.

Cohort (2015-2023); Cohort (2023-Present)

Eligibility Criteria

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

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.

You may qualify if:

• \- 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Fresh tumor biopsy samples preserved in RNAlater solution for proteomics and transcriptomics sequencing. * Fresh frozen samples stored at -80°C for imaging mass cytometry and spatial transcriptomics analysis. * Blood samples collected for metabolomics sequencing.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qin Wu

  Hangzhou Institute of Medicine (HIM), Chinese Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: April 17, 2025
• Primary Completion: December 17, 2025
• Study Completion (Estimated): November 17, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)