ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)
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|ClinicalTrials.gov Identifier: NCT02502240|
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : March 3, 2017
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.
|Condition or disease|
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 3.2%, Argentina of 4.2% and Mexico of 9.0% 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||7000 participants|
|Target Follow-Up Duration:||1 Year|
|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).|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
- Anaplastic Lymphoma Kinase (ALK) tumor rearrangement status in Non-Small Cell Lung Cancer (NSCLC) patients [ Time Frame: 1 year ]Positive or negative status. Evaluated by three diagnostic methods: (1) fluorescence in situ hybridization (FISH), (2) immunohistochemistry (IHC) and (3) real-time polymerase chain reaction (RT-qPCR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502240
|Contact: Oscar Gerardo Arrieta Rodriguez, MD MSc||+52 55 6280400 ext email@example.com|
|Contact: Andrés Felipe Cardona, MD MSc PhD.||+571 firstname.lastname@example.org|
|National Cancer Institute of Mexico||Recruiting|
|Mexico city, Distrito Federal, Mexico, 14080|
|Contact: Oscar G Arrieta, MD M Sc. 56 28 04 00 ext 353 email@example.com|
|Contact: Graciela Cruz Rico, M Sc. 5528880264 firstname.lastname@example.org|
|Principal Investigator: Oscar G Arrieta, Oncologist|
|Principal Investigator:||Oscar Gerardo Arrieta Rodriguez, MD MSc||Instituto Nacional de Cancerología Mexico city|