NCT06941948 Sleep Disorders and Tumor Immune Microenvironment
| NCT ID | NCT06941948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-05-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Title: Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer: A Prospective Cohort Study Objective: This prospective study aims to investigate the causal relationship between sleep disorders (e.g., insomnia, obstructive sleep apnea \[OSA\]) and alterations in the tumor immune microenvironment (TIME) in lung cancer patients, and to evaluate their joint effects on immunotherapy response and long-term prognosis. Study Design: Prospective observational cohort study with 3-year follow-up. Participants: Newly diagnosed primary lung cancer patients (NSCLC/SCLC) prior to treatment initiation (n = 400, target sample size\*). Exposure Groups: Stratified by sleep disorder status (confirmed via polysomnography \[OSA\] and validated questionnaires \[e.g., PSQI ≥7 for insomnia\]).
Eligibility Criteria
Inclusion Criteria: * Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy) Exclusion Criteria: * Patients with severe mental illness, other malignant tumors, or receiving sleep medication
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06941948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941948 currently recruiting?
Yes, NCT06941948 is actively recruiting participants. Contact the research team at jiang.pan@zs-hospital.sh.cn for enrollment information.
Where is the NCT06941948 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06941948 clinical trial?
NCT06941948 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 400 participants.
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