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

Plain Language Summary

Simplified for easier understanding

This observational study is looking at how sleep disorders affect the immune environment around tumors in patients with newly diagnosed stage III–IV non-small cell lung cancer (NSCLC), to better understand the connection between sleep and cancer immunity. **You may be eligible if...** - You have been newly diagnosed with stage III or IV non-small cell lung cancer - You have not yet started systemic treatment (no chemotherapy, immunotherapy, or radiation) **You may NOT be eligible if...** - You have a severe mental illness - You have another active malignant tumor - You are taking sleep medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPSQI

PSQI


Locations(1)

Zhong Shan hospital

Shanghai, China

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NCT06941948