Development and Application of Accurate Detection Technology Based on Multimodal Data of Breast Cancer Comobid Depression

NCT06938373 | Recruiting DMC

• 1 other identifier: MAD-BCD001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, observational clinical research aimed at establishing a multimodal database encompassing clinical information and gut microbiome data from a sample of over 1,000 breast cancer patients comorbid with depression. The research involves collecting cohort sample information from breast cancer patients with comorbid depression, as well as fecal, blood, and saliva specimens for metagenomic sequencing, untargeted metabolite detection, and cortisol level analysis, respectively. Based on the collected multimodal data, diagnostic, efficacy prediction, and prognostic survival prediction models for breast cancer with comorbid depression will be developed. Additionally, a precision prediction cloud platform will be designed and deployed to support data upload, model prediction, and result visualization.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• objective response rate，ORR

  The propotion defined as subjects with complete remission (CR) and partial remission (PR) among all subjects.

  2025-03-11 to 2027-03-01

Study Arms (3)

Neoadjuvant therapy breast cancer patient cohort

HR-positive breast cancer cohort under adjuvant treatment

Advanced triple-negative immunotherapy and HR-positive endocrine therapy cohorts

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with breast cancer

You may qualify if:

• Pathologically confirmed primary breast cancer; Aged 18-80 years; No prior history of malignancy other than breast cancer; Awareness of their breast cancer diagnosis; Karnofsky Performance Status (KPS) score \>70; Willing to provide blood, fecal, and saliva samples with signed informed consent.

You may not qualify if:

• Physician-diagnosed mental disorders before or after breast cancer diagnosis; Severe chronic somatic diseases (e.g., central nervous system disorders, severe head trauma, substance abuse/dependence, intellectual disability, diabetes, gynecological diseases, cardiovascular diseases, thyroid disorders, etc.); Presence of two or more primary malignancies of different tissue origins; Central nervous system (CNS) metastasis of breast cancer; Clinically diagnosed digestive system diseases (e.g., enteritis, gastritis); Use of antidepressant or anxiolytic therapy during the study; Use of medications that alter gut function or metabolism during the study; Pregnant or lactating women; Radiotherapy or chemotherapy within the past 21 days; Use of antibiotics, probiotics, prebiotics, or synbiotics within 3 months prior to the study; Other reasons deemed unsuitable for participation by investigators.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral venous blood, fecal sample, saliva and residual biopsy tissue or surgical specimens.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jun Huang，doctor

CONTACT

86-18229944886; 404369@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-03

Locations

CN (1)