Developing a database for breast cancer patients with depression
Development and Application of Accurate Detection Technology Based on Multimodal Data of Breast Cancer Comobid Depression
This study is trying to build a database that collects health information and gut bacteria data from breast cancer patients who have depression to see how it can help improve their diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06938373 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with pathologically confirmed primary breast cancer and a Karnofsky Performance Status score greater than 70.
Not a fit: Patients with a history of other malignancies, severe chronic diseases, or those currently on antidepressant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for breast cancer patients suffering from comorbid depression.
How similar studies have performed: While the approach of integrating multimodal data is innovative, similar studies have shown promise in understanding the interplay between cancer and mental health.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Changsha, Hunan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.