This study will investigate if it is possible to perform the EGFR mutation test using blood samples. If successful, this study may mean that in the future, the mutation test can be done using a blood sample, and that patients may not need to have…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study will establish whether blood (plasma) is a suitable sample type for
reliably determining the EGFR mutation status of patients with NSCLC compared
with cytology/tumour tissue.
Secondary outcome
In addition the study will also collect information about NSCLC, result of the
EGFR mutation test, how the EGFR mutation test is performed in the laboratory,
and what effect the EGFR mutation test result has on the choice of drugs used
to treat NSCLC.
Background summary
On the surface of most lung cancer cells there are proteins (receptors) called
Epidermal Growth Factor Receptors (EGFR) that play an important role in causing
many tumours to grow. A specific change to the DNA of EGFR, called a so-called
*EGFR mutation*, makes cancer cells more or less likely to respond to
anti-cancer drugs. Some hospitals perform a test to see whether the EGFR
mutation is present in the tumour or not in order to determine what drugs will
be more effective in treating the lung tumour.
The EGFR mutation test is usually performed on the tumour sample which was used
to diagnose your lung cancer. The tumour sample is obtained by procedures that
are often invasive or uncomfortable for some patients. This study will
investigate if it is possible to perform the EGFR mutation test using blood
samples. If successful, this study may mean that in the future, the mutation
test can be done using a blood sample, and that patients may not need to have
repeated sampling with uncomfortable of invasive procedures.
Study objective
This study will investigate if it is possible to perform the EGFR mutation test
using blood samples. If successful, this study may mean that in the future, the
mutation test can be done using a blood sample, and that patients may not need
to have repeated sampling with uncomfortable of invasive procedures.
Study design
You will be asked to provide a tumour/cytology sample that has been used to
diagnose your Non Small Cell Lung Cancer (NSCLC); a new biopsy will not be
required. In addition you will also be asked to provide a blood sample. Both
samples will be used for EGFR mutation testing. You will also be given the
option to consent to provide an optional additional tissue/cytology sample or
remaining material from the tumour/cytology sample used for your EGFR mutation
test for exploratory biomarker research
Study burden and risks
The study does not involve more visits to the hospital than those scheduled in
clinical practice to a patient with your disease.
The unique difference will be that you will be asked to donate an additional
blood sample of 10 ml within one of the routine blood extractions organised by
your doctor for the management of your disease.
Pepparedsleden 1
Mölndal 431 83
SE
Pepparedsleden 1
Mölndal 431 83
SE
Listed location countries
Age
Inclusion criteria
- Provision of written informed consent.
- Patients aged 18 years and older from European countries and patients aged 20 years and - older for patients from Japan.
- 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 Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI).
- Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable).
- Provision of a routine blood (plasma) sample.
Exclusion criteria
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrolment in the present study
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
- Pregnancy or breast-feeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44686.078.13 |