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Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa (ALK NSCLC MENA)

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ClinicalTrials.gov Identifier: NCT02304406
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North Africa population by using the Ventana ALK-IHC method for ALK protein detection in retrospective NSCLC clinical samples, & to evaluate the association of ALK rearrangement with clinical and pathological parameters of NSCLC patients in MENA.

Condition or disease
Non-small Cell Lung Cancer

Detailed Description:

This is a retrospective, cross-sectional non-interventional epidemiology study to investigate the prevalence of ALK rearrangement in NSCLC patients in Middle East & North Africa. Approximately 700 retained tumor tissue specimens (tissue block) of patients previously diagnosed with NSCLC will be selected & subjected to ALK immune-staining using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody combined with OptiView Benchmark System in 6-8 centers in 5-7 countries in the MENA region.

The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units & pathology departments in these study centers. The histological diagnosis will be confirmed by the pathologists. The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (Roche Diagnostics GmbH) in the selected study centers. The results of ALK testing within this study population will then be used to establish the prevalence of ALK rearrangement in MENA NSCLC patients.

The patients' characteristics, demographic, clinical and pathologic parameters will be obtained from their medical records & analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients.

The assessment of concordance of the results between FISH & IHC will be done in 2-3 centers. Results of FISH testing will be collected & recorded, if the retained tissue samples had been previously tested. If not, the Vysis FISH test will be performed, to assess the concordance between the results obtained using Vysis Break-apart FISH & Ventana IHC testing methods for ALK rearrangement detection.


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Study Type : Observational
Actual Enrollment : 449 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Retrospective Epidemiology Study Of Eml4-alk Rearrangement In Non-small Cell Lung Cancer Patients In The Middle East & North Africa.
Actual Study Start Date : January 21, 2015
Actual Primary Completion Date : February 11, 2018
Actual Study Completion Date : February 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Prevalence [number of incident cases] of ALK rearrangement in the Middle East & North Africa NSCLC patients [ Time Frame: 1 year ]
    to estimate the prevalence of ALK rearrangement in a large cohort of approximately 700 retained tissue samples of MENA NSCLC patients. The diagnostic testing of retained clinical tissue samples (tissue block) will be tested by using the Ventana IHC test for ALK protein detection.


Secondary Outcome Measures :
  1. Association of ALK rearrangement [number of incident cases] with demographic, clinical and pathological parameters in NSCLC patients [ Time Frame: 1 year ]
    The patients' characteristics, demographic, clinical and pathologic parameters will be obtained from their medical records & analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients. The samples & data collected will be coded by 'Study Subject ID' to protect patient confidentiality. No identifiable personal data will be stored.


Other Outcome Measures:
  1. Concordance [percent agreement] between Vysis FISH and Ventana IHC methods for ALK rearrangement detection in a subset of tissue samples [ Time Frame: 1 year ]
    The assessment of concordance of the results between FISH & IHC will be done in 2-3 centers. Results of FISH testing will be collected & recorded, if the retained tissue samples had been previously tested. If not, the Vysis FISH test will be performed, to assess the concordance between the results obtained using Vysis Break-apart FISH & Ventana IHC testing methods for ALK rearrangement detection.


Biospecimen Retention:   Samples With DNA
The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units & pathology departments in these study centers. The histological diagnosis will be confirmed by the pathologists. The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (Roche Diagnostics GmbH) in the selected study centers.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Since this is a retrospective epidemiology study, no patients will be enrolled. Tissue samples of non-squamous NSCLC cases less than 5 years old from each of the centers will be selected.
Criteria

Inclusion Criteria:

- 1. Histological confirmation of nonsquamous NSCLC, with any TNM stage. 2. Available and sufficient tissue sample for ALK testing 3.Tissue samples are less than 5 years old 4.Routinely processed formalin-fixed, paraffin-embedded tissue samples only (see exclusion criteria pertaining to tissue samples).

5.Histological sections mounted on glass slides must not be older than 3 months 6.Age > 18 years 7.Any ECOG Performance status 8.Still alive, or death confirmed before inclusion, or is unknown 9.Disease diagnosis and/or treatment in one of the centers, in the last 5 years, assigned to participate in the study; 10.Written informed consent for general investigational testing was previously obtained, or specifically obtained for this retrospective epidemiology study, or having a documented waiver for the Informed consent document use, as required by local regulatory authorities, &/or Research Ethics committee/Institutional Review Board.

Exclusion Criteria:

  • 1- Tumor tissue samples older than 5 year period or samples not properly stored.

    2-Tumor tissue samples fixed by using AFA, B5, Bouin's, 95% ETOH, & alcohol fixatives.

    3-Under-fixed tissue samples (i.e. < 6 hrs) 4-Tumor tissue samples that have been subject to any decalcification processes. 5-Recycled paraffin-embedded tissue samples. 6-Cut slides stored longer than 3 months. 7-Insufficient tissue samples with less tumor cells & high amount of necrosis.


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 ClinicalTrials.gov identifier (NCT number): NCT02304406


Locations
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Egypt
National Cancer Institute
Cairo / Misr Al Qadimah, Egypt
National Cancer Institute
Cairo, Egypt
Lebanon
American University in Beirut
Beirut, Lebanon
American University of Beirut
Beirut, Lebanon
Morocco
Institut National d'Oncologie
Rabat, Morocco
Saudi Arabia
King Faisal Specialty Hospital, Riyadh/Oncology Department
Riyadh 12713, Saudi Arabia
King Abdulaziz Medical City - National Guard Hospital
Riyadh, Saudi Arabia
King Faisal Specialty Hospital
Riyadh, Saudi Arabia
National Guard Hospital
Riyadh, Saudi Arabia
United Arab Emirates
Tawam Hospital
Al Ain/Al Maqam, United Arab Emirates
Tawam Hospital
Al Ain, United Arab Emirates
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02304406     History of Changes
Other Study ID Numbers: A8081046
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Keywords provided by Pfizer:
prevalence of ALK rearrangement, NSCLC, MENA

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms