ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02304406
Date of registration:	14/11/2014
Prospective Registration:	Yes
Primary sponsor:	Pfizer
Public title:	Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa ALK NSCLC MENA
Scientific title:	RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.
Date of first enrolment:	January 21, 2015
Target sample size:	449
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02304406
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Egypt	Lebanon	Morocco	Saudi Arabia	United Arab Emirates

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Intervention(s)

Primary Outcome(s)

Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement [Time Frame: 3 years]

Secondary Outcome(s)

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender [Time Frame: 3 years]

Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS) [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis [Time Frame: 3 years]

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage [Time Frame: 3 years]

Secondary ID(s)

A8081046

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	19/07/2019
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02304406

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.