NCT01562665

Brief Summary

The overall aim of the study is: To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of:

  • Patient and hospital characteristics.
  • Diagnostic and treatment approaches: initial and subsequent.
  • Follow-up patterns in clinical management.
  • Outcomes: symptoms, death, functionality, quality of life.
  • Use of resources and burden on patients and health care systems.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 22, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

February 22, 2012

Last Update Submit

May 23, 2016

Conditions

Keywords

All patients with NSCLC attending participating hospitals

Outcome Measures

Primary Outcomes (1)

  • Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information

    April 2014(26 Months)

Secondary Outcomes (1)

  • Patient-Reported Outcomes (PRO) through self-administered questionnaires and the patients will be asked to complete them at each evaluation visit(25% of the whole sample)

    April 2014(26 Months)

Study Arms (2)

All Population

Sample of patients will be invited to complete Quality of Life

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Oncology Institutes

You may qualify if:

  • Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between November 1st, 2011 and August 30th, 2012 For PRO
  • Sub-sample:
  • ability to read and write since they will be asked to participate in the PRO part of the study.
  • Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Manama, Bahrain

Location

Research Site

Doha, Qatar

Location

Research Site

Alain - AbuAhabi, United Arab Emirates

Location

Related Links

Study Officials

  • Kakil Rasul, CONSULTANT

    Hamad Medical Corporation, Doha, Qatar

    PRINCIPAL INVESTIGATOR
  • Ahmed El Khodary, CONSULTANT

    Kuwait Cancer Centre, Al Sabah Hospital, Kuwait

    PRINCIPAL INVESTIGATOR
  • Norbert Drier, CONSULTANT

    Zayed Military Hospital, Abu Dhabi, United Arab Emirates

    PRINCIPAL INVESTIGATOR
  • Farid Khalifa, CONSULTANT

    Salmaniya Medical Complex, Bahrain

    PRINCIPAL INVESTIGATOR
  • Mohamed Jaloudy, CONSULTANT

    Tawam Hospital ,Alain,Abu Dhabi, United Arab Emirates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 26, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations