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Non-small Cell Lung CancerALK NSCLC MENANCT02304406

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

An observational study of Non-small Cell Lung Cancer, run by Pfizer at 11 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
How many people
449 participants
Where
11 sitesin 5 countries
Study dates
21 Jan 2015to 11 Feb 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 5 countries.

11 sites in 5 countries

Saudi Arabia4 sites

  • King Abdulaziz Medical City - National Guard Hospital

    Riyadh

  • King Faisal Specialty Hospital, Riyadh/Oncology Department

    Riyadh

  • King Faisal Specialty Hospital

    Riyadh

  • National Guard Hospital

    Riyadh

Other trials in Saudi Arabia

Egypt2 sites

  • National Cancer Institute

    Cairo

  • National Cancer Institute

    Cairo / Misr Al Qadimah

Other trials in Egypt

Lebanon2 sites

  • American University in Beirut

    Beirut

  • American University of Beirut

    Beirut

Other trials in Lebanon

United Arab Emirates2 sites

  • Tawam Hospital

    Al Ain City

  • Tawam Hospital

    Al Ain/Al Maqam

Other trials in United Arab Emirates

Morocco1 site

  • Institut National d'Oncologie

    Rabat

Other trials in Morocco

About this study

Official title: RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.

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.

Read the 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.

Keywords
prevalence of ALK rearrangement, NSCLC, MENA
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement

    Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).

    Measured: 3 years

Secondary outcomes (13)

  1. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.

    Measured: 3 years

  2. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.

    Measured: 3 years

  3. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.

    Measured: 3 years

  4. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.

    Measured: 3 years

  5. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants.

    Measured: 3 years

  6. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants.

    Measured: 3 years

  7. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants.

    Measured: 3 years

  8. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy

    In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants.

    Measured: 3 years

  9. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)

    Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

    Measured: 3 years

  10. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status

    In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated.

    Measured: 3 years

  11. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status

    In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant.

    Measured: 3 years

  12. Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status

    In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant.

    Measured: 3 years

  13. Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection

    Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study start21 Jan 2015
  3. Primary completion11 Feb 2018
  4. Study completion11 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304406
Sponsor's protocol ID
A8081046
Acronym
ALK NSCLC MENA
Status last verified
May 2019
First submitted
14 Nov 2014
Last updated
19 Jul 2019
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer, run by Pfizer at 11 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Saudi Arabia, Egypt, Lebanon, United Arab Emirates, Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02304406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.

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