Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Registry Establishment
研究概览
简要总结
The purpose of this research study is to obtain and study clinical history, and tissue and saliva specimens if available from participants with Anaplastic Lymphoma Kinase-ALK+ Non-Small Lung Cancer(NSCLC)
详细描述
The purpose of this study is to establish a registry of clinical data and tumor specimens of patients with advanced ALK+ non-small lung cancer (NSCLC) (defined as NSCLC harboring an ALK gene rearrangement). This will allow in-depth, comprehensive genomic and immunophenotypic analyses of ALK+ tumors. Together with the clinical data, these biologic specimens will enable the conduct of basic and translational research to identify genomic and immunologic markers associated with clinical outcomes for ALK+ patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Cohort 1 - Alive Individuals
- •Men or women 18 years of age or the age of majority for their residential state of the United States, or older, at the time of consent.
- •Histologically or cytologically confirmed advanced stage IIIB-IIIC not amenable to curative approach multi-modality (e.g., chemoradiation and/or surgery) treatment, or stage IV non-small cell lung cancer (NSCLC)
- •Demonstration of having advanced ALK+ NSCLC, as assessed by fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), next-generation sequencing (NGS) or circulating tumor DNA analysis (ctDNA). For ALK FISH, fusions must have been detected in at least 15% of tumor cells.
- •Willingness to provide clinical and medical information to the study team as required.
- •Willingness to provide archival tumor tissue, if available. Patients may enroll even if no tumor tissue is available.
- •Ability to read, write and communicate in English.
- •Ability to sign a web-based informed consent form.
- •Cohort 2 - Deceased Individuals
- •Deceased individuals diagnosed with advanced ALK+ lung cancer at age 18 years or older may be studied on a case by case basis. Inclusion will require availability of adequate archived tissue and release of tissue and records by next of kin, if available.
排除标准
- •Participants who are unwilling to provide informed consent.
- •Participants who are younger than 18 years of age.
- •Participants who are unable to comply with the study procedures.
- •Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
- •Participants who have previously enrolled to the study.
结局指标
主要结局
Registry Establishment
时间窗: Up to 2 years
Establish a registry of clinical data and tumor specimens from goal of 100 patients with advanced ALK+ NSCLC (defined as NSCLC harboring an ALK gene rearrangement), for characterization of the immunophenotype and genomic landscape of ALK+ NSCLC.
次要结局
- Overall survival (OS)(Up to 2 years)
- Duration Of Therapy(Up to 2 years)
- ALK resistance mutations(Up to 2 years)
- Tumor immunophenotype(Up to 2 years)
- Genomic alterations(Up to 2 years)
研究者
Jessica Jiyeong Lin, M.D.
Principal Investigator
Massachusetts General Hospital