NCT02695849

Brief Summary

This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

March 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

3.2 years

First QC Date

February 25, 2016

Last Update Submit

July 1, 2016

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with EGFR mutations

    Day 1

Secondary Outcomes (1)

  • Percentage of Participants with types of EGFR mutations

    Day 1

Study Arms (1)

NSCLC Participants

Participants with non-squamous NSCLC will be enrolled in this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with non-squamous non-small cell lung cancer (NSCLC)

You may qualify if:

  • Informed consent form signature
  • Jordanian male and female participants greater than or equal to (\>=) 18 years of age
  • Histologically confirmed NSCLC
  • Not participating in a study that involves an investigational agent within 30 days prior to enrollment

You may not qualify if:

  • Other primary malignancy
  • Fine needle aspiration samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Amman, 11941, Jordan

Location

Unknown Facility

Amman, 13046 / 11942, Jordan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 1, 2016

Study Start

March 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

JO(2)