A Multicenter Retrospective Real-World Cohort Study of Pulmonary NUT Carcinoma With Integrated Clinical, Pathologic, and Imaging Analyses
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Three Gorges Hospital of Chongqing University
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
概览
简要总结
This study is a multi-center, retrospective observational study of patients with lung NUT carcinoma. Existing clinical records from participating hospitals will be reviewed to describe patient characteristics, treatments, and outcomes. No study-related interventions will be performed. Data will be de-identified to protect patient privacy.
详细描述
This is a multi-center, retrospective observational cohort study of lung NUT carcinoma. Eligible patients diagnosed with lung NUT carcinoma at participating hospitals will be identified based on pathology with supportive evidence of NUT immunohistochemistry (IHC) positivity and/or NUTM1 rearrangement/fusion. Data will be extracted from existing medical records and follow-up documentation, including demographics, tumor characteristics, staging, treatments, and outcomes. When available, routine-care pathology information and imaging data will be collected and de-identified.
Primary outcome: progression-free survival (PFS).
Secondary outcomes: overall survival (OS) and other routinely documented outcomes when available.
No new drugs, devices, procedures, or additional tests will be provided as part of this research. All data will be de-identified and stored with access controls according to applicable regulations and ethics approvals at each participating site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed pulmonary (lung) NUT carcinoma.
- •Evidence of NUT immunohistochemistry (IHC) positivity and/or NUTM1 rearrangement/fusion, per local pathology report.
- •Diagnosed and/or treated at a participating hospital during the study period.
- •Availability of sufficient medical record data to abstract key baseline characteristics, treatments, and outcomes.
排除标准
- •Primary tumor site not in the lung.
- •Records insufficient to confirm the diagnosis of pulmonary NUT carcinoma.
- •No follow-up or outcome information available after diagnosis (insufficient for survival/outcome assessment).
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From diagnosis through study completion (up to May 2026)
Time from initial diagnosis (index date) to first documented disease progression per routine clinical assessment or death from any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(From diagnosis through study completion (up to May 2026))