Investigating how sleep disorders affect lung cancer and immune response
Prospective Clinical Study Design: the Association of Sleep Disorders With Tumor Immune Microenvironment and Prognosis of Lung Cancer
Shanghai Zhongshan Hospital · NCT06941948
This study is trying to see how sleep problems like insomnia and sleep apnea affect the immune system and treatment outcomes in people who have just been diagnosed with lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06941948 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort study aims to explore the relationship between sleep disorders, such as insomnia and obstructive sleep apnea, and the tumor immune microenvironment in patients with lung cancer. It will involve newly diagnosed primary lung cancer patients who will be stratified based on their sleep disorder status, confirmed through polysomnography and validated questionnaires. The study will follow participants for three years to assess how these disorders impact immunotherapy responses and long-term clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed stage III-IV non-small-cell lung cancer patients who are not receiving systemic therapy.
Not a fit: Patients with severe mental illness, other malignant tumors, or those receiving sleep medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for lung cancer patients by addressing sleep disorders and their effects on immune response.
How similar studies have performed: While there is limited prospective research on this specific topic, related studies have shown that sleep disorders can influence immune responses in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy) Exclusion Criteria: * Patients with severe mental illness, other malignant tumors, or receiving sleep medication
Where this trial is running
Shanghai
- Zhong Shan hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: PAN JIANG, PHD
- Email: jiang.pan@zs-hospital.sh.cn
- Phone: 18201731016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Impact of Sleep Disorders on Tumor Immune Microenvironment and Clinical Outcomes in Lung Cancer