NCT02502240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

July 13, 2015

Last Update Submit

March 1, 2017

Conditions

Lung Cancer

Keywords

ALKLatin American

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Not lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute of Mexico

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18927303BACKGROUND

  • 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.

    PMID: 22892933BACKGROUND

  • 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.

    PMID: 25634006BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Oscar Gerardo Arrieta Rodriguez, MD MSc

    Instituto Nacional de Cancerología Mexico city

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Gerardo Arrieta Rodriguez, MD MSc

CONTACT

+52 55 6280400ogarrieta@gmail.com

Andrés Felipe Cardona, MD MSc PhD.

CONTACT

+571 6190052a_cardonaz@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of biological sciences

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)