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ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02502240
Recruitment Status : Unknown
Verified March 2017 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Recruiting
First Posted : July 20, 2015
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

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.

Condition or disease
Lung Cancer

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 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7000 participants
Observational Model: Case-Only
Time Perspective: Other
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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Both: both female and male participants are being studied Analysis of the ALK translocation was done either by FISH, IHC, or both, with an adequate amount of cancer cells. Demographic, clinical and pathological data was obtained from patients.

Inclusion Criteria:

  • Histologically confirmed lung cancer and tissue availability for ALK analysis.

Exclusion Criteria:

  • Not lung cancer

Information from the National Library of Medicine

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 identifier (NCT number): NCT02502240

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Contact: Oscar Gerardo Arrieta Rodriguez, MD MSc +52 55 6280400 ext 37045
Contact: Andrés Felipe Cardona, MD MSc PhD. +571 6190052

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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   
Contact: Graciela Cruz Rico, M Sc.    5528880264   
Principal Investigator: Oscar G Arrieta, Oncologist         
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
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Principal Investigator: Oscar Gerardo Arrieta Rodriguez, MD MSc Instituto Nacional de Cancerología Mexico city

Additional Information:

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Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Master of biological sciences, Instituto Nacional de Cancerologia de Mexico Identifier: NCT02502240     History of Changes
Other Study ID Numbers: ALK-CLICaP
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
Latin American

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases