Sleep Disorders and Tumor Immune Microenvironment
Prospective Clinical Study Design: the Association of Sleep Disorders With Tumor Immune Microenvironment and Prognosis of Lung Cancer
1 other identifier
observational
400
1 country
1
Brief 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 \[e.g., PSQI ≥7 for insomnia\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 24, 2025
April 1, 2025
1.7 years
April 16, 2025
April 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
TTP
Baseline: Immune indicators assessed at initial diagnosis (pre-treatment)
Study Arms (2)
Lung cancer-no SD
Lung cancer-SD
Interventions
Eligibility Criteria
Study type: Prospective cohort study (single center). Data sources: Recruitment Organization: Patients with newly diagnosed primary lung cancer (confirmed histopathologically or cytologically) were enrolled at \[Zhong shan hospital\]. Time frame: January 2024 to December 2026 (recruitment period). Data collection: Clinical data: electronic medical record system (EMR), imaging reports, laboratory databases. Biological samples: baseline tumor tissue (biopsy/surgical specimens), serial serum/plasma samples (baseline and treatment follow-up time points).
You may qualify if:
- Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy)
You may not qualify if:
- Patients with severe mental illness, other malignant tumors, or receiving sleep medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhong Shan hospital
Shanghai, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2025
First Posted
April 24, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share