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Sleep Disorders and Tumor Immune Microenvironment

NCT06941948 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-04-24

No results posted yet for this study

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 \[e.g., PSQI ≥7 for insomnia\]).

Conditions

  • Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer

Interventions

OTHER

PSQI

PSQI

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-01-01
Completion
2028-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941948 on ClinicalTrials.gov