RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 449
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
研究概览
简要总结
Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North Africa population by using the Ventana ALK-IHC method for ALK protein detection in retrospective NSCLC clinical samples, & to evaluate the association of ALK rearrangement with clinical and pathological parameters of NSCLC patients in MENA.
详细描述
This is a retrospective, cross-sectional non-interventional epidemiology study to investigate the prevalence of ALK rearrangement in NSCLC patients in Middle East & North Africa. Approximately 700 retained tumor tissue specimens (tissue block) of patients previously diagnosed with NSCLC will be selected & subjected to ALK immune-staining using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody combined with OptiView Benchmark System in 6-8 centers in 5-7 countries in the MENA region.
The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units & pathology departments in these study centers. The histological diagnosis will be confirmed by the pathologists. The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (Roche Diagnostics GmbH) in the selected study centers. The results of ALK testing within this study population will then be used to establish the prevalence of ALK rearrangement in MENA NSCLC patients.
The patients' characteristics, demographic, clinical and pathologic parameters will be obtained from their medical records & analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients.
The assessment of concordance of the results between FISH & IHC will be done in 2-3 centers. Results of FISH testing will be collected & recorded, if the retained tissue samples had been previously tested. If not, the Vysis FISH test will be performed, to assess the concordance between the results obtained using Vysis Break-apart FISH & Ventana IHC testing methods for ALK rearrangement detection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Histological confirmation of nonsquamous NSCLC, with any TNM stage.
- •Available and sufficient tissue sample for ALK testing 3.Tissue samples are less than 5 years old 4.Routinely processed formalin-fixed, paraffin-embedded tissue samples only (see exclusion criteria pertaining to tissue samples).
- •5.Histological sections mounted on glass slides must not be older than 3 months 6.Age > 18 years 7.Any ECOG Performance status 8.Still alive, or death confirmed before inclusion, or is unknown 9.Disease diagnosis and/or treatment in one of the centers, in the last 5 years, assigned to participate in the study; 10.Written informed consent for general investigational testing was previously obtained, or specifically obtained for this retrospective epidemiology study, or having a documented waiver for the Informed consent document use, as required by local regulatory authorities, &/or Research Ethics committee/Institutional Review Board.
排除标准
- •1- Tumor tissue samples older than 5 year period or samples not properly stored.
- •2-Tumor tissue samples fixed by using AFA, B5, Bouin's, 95% ETOH, & alcohol fixatives.
- •3-Under-fixed tissue samples (i.e. < 6 hrs) 4-Tumor tissue samples that have been subject to any decalcification processes. 5-Recycled paraffin-embedded tissue samples. 6-Cut slides stored longer than 3 months. 7-Insufficient tissue samples with less tumor cells & high amount of necrosis.
结局指标
主要结局
Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
时间窗: 3 years
Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).
次要结局
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status(3 years)
- Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy(3 years)
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status(3 years)