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NCT Number: NCT06938373

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. objective response rate,ORR

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Huang,doctor

CONTACT

[email protected]

86-18229944886

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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