Developing a database for breast cancer patients with depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a multimodal database that includes clinical information and gut microbiome data from over 1,000 breast cancer patients who also experience depression. Researchers will collect various biological samples, including fecal, blood, and saliva, to perform metagenomic sequencing, metabolite detection, and cortisol level analysis. The goal is to develop predictive models for diagnosis, treatment efficacy, and survival outcomes based on the gathered data. Additionally, a precision prediction cloud platform will be established to facilitate data management and result visualization.

Why it matters

Who can join: the full rules

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:

* 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.

Where it's running

• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Jun Huang，doctor
• Email: 404369@csu.edu.cn
• Phone: 86-18229944886

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.