Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02502240
Status:
UNKNOWN
Last Update Posted:
2017-03-03
First Post:
2015-07-13
Brief Title:
ALK Rearrangements in Lung Adenocarcinoma Epidemiology in Latin America CLICaP
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
Frequency of ALK Rearrangements in Non Small-Cell Lung Cancer in Latin America The Latin-American Consortium for the Investigation of Lung Cancer CLICaP
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries
Latin American countries are heterogeneous in terms of lung cancer incidence ethnicity and exposure to potential carcinogens The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase EML4-ALK translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic
Latin American countries are heterogeneous in terms of lung cancer incidence ethnicity and exposure to potential carcinogens The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase EML4-ALK translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic
Detailed Description:
The precise frequency of ALK in Latin American population has not been determined Studies isolated in some Latin American countries like Brazil report a frequency of 32 Argentina of 42 and Mexico of 90 of ALK fusion in a small number with lung cancer Reliable information about ALK frequencies and disparities among ethnic groups is critical Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC Discusses the difficulty of having a single diagnostic test for this chromosome abnormality
The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents Currently the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization FISH for selecting patients for ALK-tyrosine kinase inhibitors TKI therapy according to the United States Food and Drug Administration FDA But an important aspect is the amount of available tumor present in a determined sample given the labor-intensive nature and cost of the test there has been interest in validating other screening and diagnostic tools Recent evidence suggests that ALK Immunohistochemistry IHC instruments globally protocols can be very effective in the detection of ALK rearrangement in NSCLC ALK tumors expressing the fusion ALK protein
The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents Currently the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization FISH for selecting patients for ALK-tyrosine kinase inhibitors TKI therapy according to the United States Food and Drug Administration FDA But an important aspect is the amount of available tumor present in a determined sample given the labor-intensive nature and cost of the test there has been interest in validating other screening and diagnostic tools Recent evidence suggests that ALK Immunohistochemistry IHC instruments globally protocols can be very effective in the detection of ALK rearrangement in NSCLC ALK tumors expressing the fusion ALK protein
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None