Trials Sponsors Conditions Drugs Pricing

Conditions

EGFR Mutation Status in aNSCLC Patients

Keywords

EGFRaNSCLCmutation statusdiagnostic studyRussiaChinaAsia

Outcome Measures

Primary Outcomes (6)

Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
At Screening
Tumour EGFR Mutation by Subtype
Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
At Screening
Tumour EGFR Mutation Status by Histology
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.
At Screening
Overall Plasma EGFR Mutation Status
Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.

Secondary Outcomes (17)

Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
At Screening
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
At Screening
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
At Screening
Tumour EGFR Mutation Testing
At Screening
Tumour EGFR Mutation Testing Rates
At Screening
+12 more secondary outcomes

Study Arms (1)

Locally advanced/metastatic NSCLC pats.

OTHER

Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy)

Genetic: EGFR mutation test

Interventions

EGFR mutation testGenetic

EGFR mutation being tested in tissue and blood

Also known as: Determination of EGFR mutation done at the Pathology lab

Locally advanced/metastatic NSCLC pats.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC
Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naive (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (71)

Research Site

Campbelltown, New South Wales, Australia

Research Site

Coffs Harbour, New South Wales, Australia

Research Site

Concord, New South Wales, Australia

Research Site

Tamworth, New South Wales, Australia

Research Site

Tweed Heads, New South Wales, Australia

Research Site

Wahroonga, New South Wales, Australia

Research Site

Brisbane, Queensland, Australia

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Haiyi Jiang/Asia Medical Director
Organization: AstraZeneca

Study Officials

Rose McCormack, PhD
AstraZeneca, PHB
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

3,500 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

February 27, 2013

Actual (reported)

Asia Pacific and Russia Diagnostic Study for EGFR Testing

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (17)

Study Arms (1)

Locally advanced/metastatic NSCLC pats.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (71)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (17)

Study Arms (1)

Locally advanced/metastatic NSCLC pats.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (71)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations