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Trial registered on ANZCTR


Registration number
ACTRN12613000739718
Ethics application status
Approved
Date submitted
1/07/2013
Date registered
3/07/2013
Date last updated
30/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Blood Diagnostic test for epidermal growth factor receptor (EGFR) mutations
Scientific title
EGFR Mutation Blood Test Evaluation and Assessment of Changes in Sensitivity Resulting from Initiation of First
Line Treatment of Advanced Adenocarcinoma of the Lung Diagnostic (EMERALD) Study
Secondary ID [1] 282769 0
Nil
Universal Trial Number (UTN)
Trial acronym
EMERALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
EGFR Mutation Blood Test Evaluation in Non Small Cell Lung Cancer 289517 0
Condition category
Condition code
Cancer 289842 289842 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will provide 2 blood samples during the course of the study for validation of a blood-based test for EGFR mutation.
Blood samples will be collected before drug therapy and another taken between 14 to 21 days after drug therapy has commenced.
Blood samples will be sent to a central laboratory where DNA is extracted and analysed for epidermal growth factor receptor (EGFR) gene mutations.
Intervention code [1] 287439 0
Diagnosis / Prognosis
Comparator / control treatment
EGFR mutation status reported via tissue testing for those patients where this information is available.
Source of this information is patients' hopsital records; also these samples would have been taken from a newly diagnosed NSCLC patient less than two months previous to enrolment.
Control group
Historical

Outcomes
Primary outcome [1] 289908 0
To measure the level of concordance between EGFR mutation status reports (i.e. positive or negative) obtained for the same patients via tissue and blood-based testing.
Timepoint [1] 289908 0
At both interim (Jan-14) and final analysis (Nov-15)
Secondary outcome [1] 303530 0
To determine the proportion of patients reporting EGFR mutation positive on tissue report and negative on plasma in the pre-treatment setting.
Timepoint [1] 303530 0
At both interim (Jan-14) and final analysis (Nov-15)
Secondary outcome [2] 303531 0
To determine the proportion of patients reporting EGFR mutation positive on plasma report and negative on tissue in the pre-treatment setting.
Timepoint [2] 303531 0
At both interim (Jan-14) and final analysis (Nov-15)
Secondary outcome [3] 303532 0
To determine the prevalence of EGFR mutations determined by tissue for all patients enrolled and amongst those with evaluable tissue.
Timepoint [3] 303532 0
At both interim (Jan-14) and final analysis (Nov-15)

Eligibility
Key inclusion criteria
For inclusion in the study subjects should fulfil the following criteria:
1. Provision of informed consent prior to any study specific procedures
2. Stage IIIB or IV adenocarcinoma of the lung
3. Age > 18 years old
4. Have had a lung tissue biopsy that is archived and available for EGFR gene testing or be a candidate for a new biopsy
5. Considered clinically suitable for EGFR TKI therapy or chemotherapy as standard first line treatment
6. WHO or ECOG Performance Status equal or less than 2 and life expectancy is greater than or equal to12 weeks.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous enrolment in the present study
3. Participation in another clinical study with any investigational product/device during the last 3 months
4. Pregnancy or breast feeding (women of child-bearing potential)
5. Prior systemic cytotoxic chemotherapy within 6 months
6. Radiation therapy within 4 weeks prior to provision of consent
7. High risk for poor compliance with therapy or follow-up as assessed by investigator
8. Any evidence of severe or uncontrolled diseases eg, unstable or uncompensated respiratory, cardiac (including arrhythmias), hepatic or renal disease.
9. Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood in previous 4 weeks)
10. History of bleeding diathesis (i.e. disseminated intravascular coagulation (DIC), clotting factor deficiency etc) or long-term anticoagulant therapy (other than anti-platelet therapy and low dose warfarin).
11. Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
12. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the target lesion
13. Active, uncontrolled infection
14. Previous or current treatment with an EGFR TKI

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1187 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 1188 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 1189 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 1190 0
Newcastle Private Hospital - New Lambton Heights

Funding & Sponsors
Funding source category [1] 287538 0
Commercial sector/Industry
Name [1] 287538 0
AstraZeneca Pty Ltd
Address [1] 287538 0
Alma Road
North Ryde NSW 2113
Country [1] 287538 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca Pty Ltd
Address
66 Talavera Road
Macquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 286290 0
None
Name [1] 286290 0
n/a
Address [1] 286290 0
n/a
Country [1] 286290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289517 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 289517 0
Level 9, 8 Central Avenue
Australian Technology Park
Eveleigh NSW 2015
Ethics committee country [1] 289517 0
Australia
Date submitted for ethics approval [1] 289517 0
Approval date [1] 289517 0
10/12/2012
Ethics approval number [1] 289517 0
EC00414

Summary
Brief summary
This study is exploring whether a blood test might be a feasible additional or alternative diagnostic test to a biopsy in patients with lung cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have stage IIIB or IV adenocarcinoma of the lung. You should have had a lung tissue biopsy that is archived and available for testing, or be a candidate for a new biopsy.

Trial details
All participants in this study will provide 2 blood samples (one before drug therapy and another taken between 14 to 21 days after drug therapy has commenced) to be tested for the epidermal growth factor receptor (EGFR) mutation using a new test kit. The results of this test will be compared to the EGFR mutation status reported via tissue testing for those patients where this information is available. Knowledge of EGFR gene status (positive or negative) can help guide treatment decisions.

Based on these results we aim to determine whether the blood test is a feasible alternative or additional approach to a 'traditional' biopsy in evaluating EGFR mutation status.
Trial website
Trial related presentations / publications
AstraZeneca report - D713L00136 EMERALD Exploratory Study Synopsis.
.
Public notes
Attachments [1] 1278 1278 0 0

Contacts
Principal investigator
Name 41162 0
Dr Nick Pavlakis
Address 41162 0
Department of Medical Oncology
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 41162 0
Australia
Phone 41162 0
+61 2 9926 5015
Fax 41162 0
Email 41162 0
pavlakis@med.usyd.edu.au
Contact person for public queries
Name 41163 0
Dr Simon Shaw
Address 41163 0
AstraZeneca Pty Ltd
66 Talavera Road
Macquarie Park NSW 2113
Country 41163 0
Australia
Phone 41163 0
+61 2 9978 3500
Fax 41163 0
Email 41163 0
Simon.Shaw@astrazeneca.com
Contact person for scientific queries
Name 41164 0
Dr Simon Shaw
Address 41164 0
AstraZeneca Pty Ltd
66 Talavera Road
Macquarie Park NSW 2113
Country 41164 0
Australia
Phone 41164 0
+61 2 9978 3500
Fax 41164 0
Email 41164 0
Simon.Shaw@astrazeneca.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary