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

Lung Cancer Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02502240
• Other study ID #: ALK-CLICaP
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2015
• Last updated: March 1, 2017
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: Oscar Gerardo Arrieta Rodriguez, MD MSc
• Phone: +52 55 6280400
• Email: ogarrieta[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not lung cancer

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Mexico	National Cancer Institute of Mexico	Mexico city	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Arrieta O, Cardona AF, Martín C, Más-López L, Corrales-Rodríguez L, Bramuglia G, Castillo-Fernandez O, Meyerson M, Amieva-Rivera E, Campos-Parra AD, Carranza H, Gómez de la Torre JC, Powazniak Y, Aldaco-Sarvide F, Vargas C, Trigo M, Magallanes-Maciel M, Otero J, Sánchez-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):838-43. doi: 10.1097/JTO.0000000000000481. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaplastic Lymphoma Kinase (ALK) tumor rearrangement status in Non-Small Cell Lung Cancer (NSCLC) patients	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).	1 year