RecruitingNCT06941948

Sleep Disorders and Tumor Immune Microenvironment

Prospective Clinical Study Design: the Association of Sleep Disorders With Tumor Immune Microenvironment and Prognosis of Lung Cancer


Sponsor

Shanghai Zhongshan Hospital

Enrollment

400 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy)

Exclusion Criteria1

  • Patients with severe mental illness, other malignant tumors, or receiving sleep medication

Interventions

OTHERPSQI

PSQI


Locations(1)

Zhong Shan hospital

Shanghai, China

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NCT06941948