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临床试验/NCT01662635
NCT01662635已完成不适用

CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p (EML4-ALK) INVERSION IN MEXICAN POPULATION.

Instituto Nacional de Cancerologia de Mexico1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
FISH, IHC, RT-qPCR Comparison

研究概览

简要总结

Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.

详细描述

Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.

FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with >15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning.

The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population.

Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • The only inclusion criterion was the availability of tissue for biomarker studies.

排除标准

  • Disease Progression

结局指标

主要结局

FISH, IHC, RT-qPCR Comparison

时间窗: TWO YEARS

200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Cancerologia de Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar Gerardo Arrieta Rodríguez MD

MD and medical oncologist

Instituto Nacional de Cancerologia de Mexico

研究点 (1)

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