Prospective Clinical Study Design: the Association of Sleep Disorders With Tumor Immune Microenvironment and Prognosis of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- TTP
研究概览
简要总结
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]).
详细描述
- Background support Sleep disorders are common in patients with lung cancer, and the incidence is as high as 52.6%-70%, which is related to tumor progression and immunosuppression. Animal experiments have shown that circadian rhythm disruption can reshape the tumor microenvironment, suppress immune responses (such as macrophage dysfunction), and lead to accelerated tumor growth.
o Clinical data show that the immune status of lung cancer patients, such as PD-L1 expression, T cell infiltration level, is closely related to treatment response and survival rate. However, there is still a lack of prospective research evidence on how sleep disorders affect the progression of lung cancer by regulating the immune microenvironment. 2. Scientific hypothesis
It is hypothesized that sleep disorders (e.g., insomnia, circadian rhythm disruption) affect the tumor immune microenvironment of lung cancer patients through the following mechanisms:
- inhibits the activity of anti-tumor immune cells, such as CD8+ T cells and NK cells;
- promotes the infiltration of immunosuppressive cells (e.g., regulatory T cells, M2 macrophages);
- up-regulates the expression of proinflammatory factors (e.g., IL-6, TNF-α) and inhibits immune checkpoints (e.g., PD-L1), thereby accelerating tumor progression and reducing treatment efficacy.
- Study design and methods
- Study type Prospective cohort study, stratified analysis of sleep disorder group and non-sleep disorder group, followed up for 1-3 years.
- Study subjects
- Inclusion criteria: patients with newly diagnosed stage Ⅲ-Ⅳ non-small cell lung cancer (NSCLC) who had not received systemic therapy (chemotherapy, immunotherapy or radiotherapy);
- Exclusion criteria: patients with serious mental illness, other malignant tumors or receiving sleep medication;
- According to the Pittsburgh Sleep Quality Index (PSQI) score, PSQI≥7 were divided into sleep disorder group, PSQI<7 were divided into control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed stage III-IV non-small-cell lung cancer (NSCLC) not receiving systemic therapy (chemotherapy, immunotherapy, or radiotherapy)
排除标准
- •Patients with severe mental illness, other malignant tumors, or receiving sleep medication
结局指标
主要结局
TTP
时间窗: Baseline: Immune indicators assessed at initial diagnosis (pre-treatment)
次要结局
未报告次要终点