Status:
RECRUITING
Development and Application of Accurate Detection Technology Based on Multimodal Data of Breast Cancer Comobid Depression
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18-80 years
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06938373
Start Date
March 11 2025
End Date
April 1 2027
Last Update
April 22 2025
Active Locations (1)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000