Exploration Study of Molecular Biomarkers for Tumor-related Anxiety and Depression

NCT07476534 | Not Yet Recruiting

• 1 other identifier: Chase020
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Solid Tumor Malignancies

Keywords

Solid tumor malignancies; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Clear tumor-derived protein-related tumor-related anxiety and depression molecular markers

  Clear tumor-derived protein-related tumor-related anxiety and depression molecular markers

  2026.03-2026.12

Secondary Outcomes (1)

• A tumor-related anxiety and depression risk assessment model established based on the expression levels of tumor-derived proteins

  2027.05

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with solid tumors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

姬 颖 华, Graduate student

CONTACT

03734402543; 54234317@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03