Exploration Study of Molecular Biomarkers for Tumor-related Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Clear tumor-derived protein-related tumor-related anxiety and depression molecular markers
研究概览
简要总结
Identifying and validating molecular biomarkers associated with tumor-related anxiety and depression. By integrating psychological assessment data from clinical tumor patients with molecular detection results, and utilizing clinically accessible samples such as tumor tissues and sera from clinical cohorts, this study aims to clinically validate the tumor-derived proteins previously identified by our team as having potential regulatory roles. The goal is to clarify the clinical value of tumor-derived proteins as molecular biomarkers for tumor-related anxiety and depression, providing a molecular basis for early screening and risk stratification. Alternatively, it seeks to establish a tumor-related anxiety and depression risk assessment model based on the expression levels of tumor-derived proteins, offering a reference for the precise identification and targeted intervention of psychological disorders in tumor patients.
详细描述
Exploration Research on Molecular Markers of Tumor-Related Anxiety and Depression I.Research Background Tumors are major diseases threatening the health of the Chinese population. In 2020, China reported 4.57 million new cases and 3 million deaths from malignant tumors, both ranking first globally [1]. Tumor-related anxiety and depression are psychological and mental disorders affecting 30%-70% of tumor patients, ranking as one of the most common comorbidities in tumor clinical settings. Annually, over 10 million tumor patients globally experience reduced treatment adherence and lower quality of life due to tumor-related psychological disorders [2]. Tumor-related anxiety and depression pose significant harm to patients, not only exacerbating their physical discomfort but also significantly reducing treatment adherence and clinical efficacy, increasing the risk of tumor recurrence and metastasis, and directly leading to poorer long-term survival outcomes. However, to date, there is still a lack of specific early screening molecular markers for tumor-related anxiety and depression in clinical practice. Current intervention strategies primarily rely on symptomatic psychological counseling and non-specific anti-anxiety and antidepressant medications, lacking targeted and precise intervention approaches, resulting in many patients' psychological disorders not being identified or effectively treated early. The field of tumor psychological diagnosis and treatment in China is underdeveloped, with an incomplete clinical diagnostic system, showing a significant gap compared to developed Western countries. Surgery, radiotherapy, chemotherapy, and immunotherapy are the main clinical treatment methods for malignant tumors. Due to the complex pathogenesis of tumors, diverse pathological types, and individual differences in patients' physiological conditions and psychological tolerance, the onset, severity, and intervention outcomes of tumor-related anxiety and depression exhibit significant heterogeneity. There remains substantial room for improvement in the precise screening, risk stratification, and targeted intervention of these psychological disorders. Building on the extensive clinical tumor samples from the Chinese population and molecular mechanism research data accumulated by our team [3], as well as the foundational research confirming that tumor-derived proteins can mediate central nervous system inflammation and emotional abnormalities, there are currently no reported clinical studies on the correlation between tumor-derived proteins and the levels of anxiety and depression in tumor patients. It is urgent to conduct clinical research to clarify the intrinsic relationship between the two, providing new molecular targets and clinical evidence for the early screening and precise intervention of tumor-related anxiety and depression.
Main References
- Hyuna Sung., et al., Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA CANCER J CLIN 2021;71:209-249.
- Vita G., et al., Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006.
- Xu Chen., et al. GRP75 triggers white adipose tissue browning to promote cancer-associated cachexia. Signal Transduction and Targeted Therapy. 2024, 26;9(1):253.
II.Research Objectives and Significance
- Research Objectives To identify and validate molecular biomarkers associated with tumor-related anxiety and depression. By integrating psychological assessment data from clinical cancer patients with molecular detection results, and utilizing clinically accessible samples such as tumor tissues and sera from clinical cohorts, this study aims to clinically validate the potential regulatory tumor-derived proteins previously identified by our team. The goal is to clarify the clinical value of tumor-derived proteins as molecular biomarkers for tumor-related anxiety and depression, providing a molecular basis for early screening and risk stratification of these conditions. Alternatively, it seeks to establish a tumor-related anxiety and depression risk assessment model based on the expression levels of tumor-derived proteins, offering a reference for the precise identification and targeted intervention of psychological disorders in cancer patients.
- Research Significance The research outcomes will yield proprietary intellectual property rights for novel molecular targets and associated biomarkers for the screening and intervention of tumor-related anxiety and depression, and promote their translation into clinical diagnostic and therapeutic applications. This study will provide critical data for classifying cancer patients into psychological intervention tiers based on their anxiety and depression risk levels, supporting the precise screening and personalized intervention of psychological disorders in clinical oncology, and contributing to the enhancement of the comprehensive cancer treatment system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with solid tumors aged ≥18 years and an expected survival period of ≥3 months;
- •Patients who meet clinical diagnostic criteria and are pathologically/histologically confirmed as having solid tumors, including liver cancer patients (diagnosable by imaging);
- •Patients who can complete standardized stratified assessments for tumor-related anxiety and depression, and are able to cooperate with researchers in completing psychological scales such as the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). They have not received any anti-anxiety/depression medications, professional psychological counseling, or psychiatric interventions before scale assessment;
- •Patients with clear consciousness, normal language communication, comprehension, and cognitive abilities, without a history of psychiatric disorders, and who can independently provide feedback on research-related information and cooperate with follow-up;
- •Patients who voluntarily participate in the study, fully understand the research objectives, procedures, potential risks, and benefits, and have signed a written informed consent form;
- •Patients who can cooperate in completing the required laboratory tests (complete blood count, blood biochemistry, coagulation function, etc.) and clinical data collection before and during the perioperative period to ensure the completeness of research data.
排除标准
- •Pregnant or lactating women;
- •Patients aged <21 years at first visit and with an expected survival period of <3 months;
- •Patients who have previously received anti-anxiety/depression medications or professional psychological interventions;
- •Patients with a history or current diagnosis of psychiatric disorders, including schizophrenia, bipolar disorder, severe cognitive dysfunction, mental retardation, or those who cannot cooperate with SAS/SDS scale assessment or have contraindications to scale evaluation;
- •Patients with severe organ dysfunction or severe underlying diseases, including: liver failure (Child-Pugh C grade), renal failure (serum creatinine >250 μmol/L or >2.83 mg/dL), New York Heart Association (NYHA) Class IV heart failure, active pulmonary tuberculosis, HIV infection, etc. (to be determined);
- •Patients with contraindications to tumor tissue or blood sample collection, including coagulation disorders (INR >1.5, platelets <50×10⁹/L), severe bleeding tendency, or surgical specimens that cannot meet detection requirements (e.g., >50% necrotic tissue, insufficient tissue amount);
- •Patients with emotional abnormalities due to non-tumor factors, including hyperthyroidism/hypothyroidism, severe malnutrition, chronic wasting diseases, or psychological stress disorders;
- •Patients who have undergone non-tumor-related surgical procedures, enteral/parenteral nutrition support within the past 1 month, or have clinical symptoms such as gastrointestinal mechanical obstruction, intractable vomiting, ascites, significant edema, or large pleural effusion;
- •Patients who are planned or currently using medications that may affect emotional assessment or protein expression detection during the study, including: long-term oral corticosteroids, 5-HT receptor agonists/antagonists (SSRIs, etc., even short-term use within 2 weeks before sampling is excluded), antipsychotic drugs, or gestagenic synthetic steroid derivatives (short-term inhaled/local use of steroids or intermittent use of inhaled bronchodilators are excluded);
- •Patients with incomplete clinical data, inability to cooperate with research-related follow-up and testing, or those who refuse to sign the informed consent form or have poor compliance.
研究组 & 干预措施
Anxiety and depression group
First, basic patient information, including age, gender, height, weight, BMI, education level, marital status, smoking and drinking history, medical history, drug allergy history, etc.; second, tumor-related clinical information, including tumor type, pathological histological type, tumor differentiation degree, TNM stage, tumor size, lymph node metastasis status, etc.; third, research-specific assessment information, including the HADS (Hospital Anxiety and Depression Scale) score results, scale assessment time, sample collection time, etc. Identify factors closely related to the anxiety and depression levels of tumor patients, and clarify the association between tumor-derived protein expression levels and tumor-related anxiety and depression, as well as their independent effects.
Non-anxiety-depressed group
First, basic patient information, including age, gender, height, weight, BMI, education level, marital status, smoking and drinking history, medical history, drug allergy history, etc.; second, tumor-related clinical information, including tumor type, pathological histological type, tumor differentiation degree, TNM stage, tumor size, lymph node metastasis status, etc.; third, research-specific assessment information, including the HADS (Hospital Anxiety and Depression Scale) score results, scale assessment time, sample collection time, etc. Identify factors closely related to the anxiety and depression levels of tumor patients, and clarify the association between tumor-derived protein expression levels and tumor-related anxiety and depression, as well as their independent effects.
结局指标
主要结局
Clear tumor-derived protein-related tumor-related anxiety and depression molecular markers
时间窗: 2026.03-2026.12
Clear tumor-derived protein-related tumor-related anxiety and depression molecular markers
次要结局
- A tumor-related anxiety and depression risk assessment model established based on the expression levels of tumor-derived proteins(2027.05)
研究者
Yinghua Ji
Department Head
The First Affiliated Hospital of Xinxiang Medical College