Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07476534
Eligibility Criteria:
Inclusion Criteria:
1. Patients with solid tumors aged ≥18 years and an expected survival period of ≥3 months;
2. Patients who meet clinical diagnostic criteria and are pathologically/histologically confirmed as having solid tumors, including liver cancer patients (diagnosable by imaging);
3. 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;
4. 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;
5. 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;
6. 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.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Patients aged \<21 years at first visit and with an expected survival period of \<3 months;
3. Patients who have previously received anti-anxiety/depression medications or professional psychological interventions;
4. 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;
5. 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);
6. 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);
7. Patients with emotional abnormalities due to non-tumor factors, including hyperthyroidism/hypothyroidism, severe malnutrition, chronic wasting diseases, or psychological stress disorders;
8. 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;
9. 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);
10. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07476534
Study Brief:
Protocol Section:
NCT07476534