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RecruitingNCT06938373Updated Apr 22, 2025

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

An observational study in Breast Neoplasms, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with breast cancer

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Neoadjuvant therapy breast cancer patient cohort
  • HR-positive breast cancer cohort under adjuvant treatment
  • Advanced triple-negative immunotherapy and HR-positive endocrine therapy cohorts
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What researchers measure

Primary outcomes

  1. objective response rate,ORR

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

    Time frame: 2025-03-11 to 2027-03-01

07

Study locations

1 of 1 sites recruiting
  • Xiangya Hospital of Central South University
    Changsha, Hunan 410000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06938373
Lead sponsor
Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Mar 11, 2025
Primary completion
Mar 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Apr 22, 2025

Study contacts

Jun Huang,doctor
Contact
404369@csu.edu.cn
86-18229944886

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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