NCT06941948Recruiting
Sleep Disorders and Tumor Immune Microenvironment
Prospective Clinical Study Design: the Association of Sleep Disorders With Tumor Immune Microenvironment and Prognosis of Lung Cancer
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 \[e.g., PSQI ≥7 for insomnia\]).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 16 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06941948
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 May 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe mental illness, other malignant tumors, or receiving sleep medication
Who the study is looking for
- Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy)
Age in the registry: 18 years to 70 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhong Shan hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.