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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
View:

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

Locations
Other Locations
China
Zhong Shan hospital
RECRUITING
Shanghai
Contact Information
Primary
PAN JIANG, PHD
jiang.pan@zs-hospital.sh.cn
18201731016
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 400
Treatments
Lung cancer-no SD
Lung cancer-SD
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov