A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer

NCT06953765 | Not Yet Recruiting

• 1 other identifier: 2025-4-24-Prospective-SD-PD1
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1/PD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.

Conditions

Lung Cancer (NSCLC); Sleep Disorders, Circadian Rhythm; PD-1

Outcome Measures

Primary Outcomes (1)

• pCR

  Pathological complete response (pCR)

  From enrollment to the end of treatment at two years"

Study Arms (1)

lung cancer-sleep disorders

Lung cancer patients treated with PD1 immunotherapy were divided into sleep disorders and non-sleep disorders groups.

Other: PSQI; Other: PQSI

Interventions

PSQI OTHER

Prospective observational cohort study: Cohort o: Stratified according to baseline sleep disorder severity (PSQI score ≥7 vs. \<7).

lung cancer-sleep disorders

PQSI OTHER

PQSI-Sleep quality assessment scale

lung cancer-sleep disorders

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed primary lung cancer (confirmed histopathologically or cytologically) were enrolled at Zhong shan hospital fromJune 2025

You may qualify if:

• Diagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.
• Be able to understand the study and provide informed consent

You may not qualify if:

• Coexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: 20-30 ml of blood was collected at each visit, divided into multiple tubes (e.g. EDTA tubes, coagulation tubes) according to laboratory needs. Tumor tissue samples: if there is surgery or biopsy, tumor tissue samples are collected and sent to a specialized laboratory for immunoassay.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Zilong Liu

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Jiang

CONTACT

18201731016; jiang.pan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04