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

NCT ID: NCT02502240

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not lung cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Oscar Gerardo Arrieta Rodríguez MD

Master of biological sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar Gerardo Arrieta Rodriguez, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerología Mexico city

Locations

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National Cancer Institute of Mexico

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Oscar Gerardo Arrieta Rodriguez, MD MSc

Role: CONTACT

+52 55 6280400 ext. 37045

Andrés Felipe Cardona, MD MSc PhD.

Role: CONTACT

+571 6190052

Facility Contacts

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Oscar G Arrieta, MD M Sc.

Role: primary

56 28 04 00 ext. 353

Graciela Cruz Rico, M Sc.

Role: backup

5528880264

References

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Takeuchi K, Choi YL, Soda M, Inamura K, Togashi Y, Hatano S, Enomoto M, Takada S, Yamashita Y, Satoh Y, Okumura S, Nakagawa K, Ishikawa Y, Mano H. Multiplex reverse transcription-PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res. 2008 Oct 15;14(20):6618-24. doi: 10.1158/1078-0432.CCR-08-1018.

Reference Type BACKGROUND
PMID: 18927303 (View on PubMed)

Lopes LF, Bacchi CE. Anaplastic lymphoma kinase gene rearrangement in non-small-cell lung cancer in a Brazilian population. Clinics (Sao Paulo). 2012 Jul;67(7):845-7. doi: 10.6061/clinics/2012(07)23. No abstract available.

Reference Type BACKGROUND
PMID: 22892933 (View on PubMed)

Arrieta O, Cardona AF, Martin C, Mas-Lopez L, Corrales-Rodriguez L, Bramuglia G, Castillo-Fernandez O, Meyerson M, Amieva-Rivera E, Campos-Parra AD, Carranza H, Gomez de la Torre JC, Powazniak Y, Aldaco-Sarvide F, Vargas C, Trigo M, Magallanes-Maciel M, Otero J, Sanchez-Reyes R, Cuello M. Updated Frequency of EGFR and KRAS Mutations in NonSmall-Cell Lung Cancer in Latin America: The Latin-American Consortium for the Investigation of Lung Cancer (CLICaP). J Thorac Oncol. 2015 May;10(5):838-843. doi: 10.1097/JTO.0000000000000481.

Reference Type BACKGROUND
PMID: 25634006 (View on PubMed)

Other Identifiers

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ALK-CLICaP

Identifier Type: -

Identifier Source: org_study_id

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