An Observational Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Suspicious LEMS
研究概览
简要总结
This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. Screening and/or medical record review for symptoms associated with Lambert Eaton Myasthenic Syndrome (LEMS) will be conducted.
详细描述
This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. All eligible subjects enrolled will undergo a brief, symptom directed neurological evaluation and VGCC antibody testing (to be performed at a participating Quest laboratory). The results (positive/negative) of VGCC antibody testing will be documented as well as the receptor type P, Q or N.
These tests will be repeated quarterly (Q3 months) for the duration of the study.
If at any visit the subject is found to be BOTH neurologically suggestive of having LEMS and the VGCC Ab test is positive, then the subject is considered to be Clinically Suspicious of having LEMS. At any visit if a subject meets the criteria of Clinically Suspicious of LEMS. the end of study visit will be completed. Once the End of study visit is completed no further treatment information will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women meeting Age of Majority (AOM) at the time of consent
- •Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
- •Any diagnosis of SCLC
- •Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
- •Willing to comply with the requirements of the study
排除标准
- •Has been diagnosed with non-tumor Lamber-Eaton Myasthenic syndrome (LEMS) > 1 year prior to the SCLC diagnosis.
- •Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements
结局指标
主要结局
Suspicious LEMS
时间窗: 1 year
Incidence of clinically suspicious LEMS diagnosis
次要结局
未报告次要终点