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Sleep Disorders and Tumor Immune Microenvironment

RECRUITINGSponsored by Shanghai Zhongshan Hospital
Actively Recruiting
SponsorShanghai Zhongshan Hospital
Started2025-05-01
Est. completion2027-01-01
Eligibility
Age18 Years – 70 Years
View on ClinicalTrials.gov →

NCT06941948

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

Age: 18 Years – 70 Years
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

Conditions3

CancerImpact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung CancerLung Cancer

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