Non-Small Cell Lung CancerNCT00815971
Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib
An observational study of Non-Small Cell Lung Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer who will start treatment with erlotinib
Who may be able to join
- Patients who are starting treatment with erlotinib and who has who has signed the informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
department of oncology, University Hospital of Aarhus, Nørrebrogade 44
8000 Aarhus
Britta Weber, MD, +4589493333, doctorweber@stofanet.dk
Peter meldgaard, PhD MD, +4589493333, peter.meldgaard@dadlnet.dk
About this study
Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.
The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.
Read more
In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.
The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.
Read the detailed description
Aim:
- To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
- In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
- In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR mutations, EGFR inhibitor, erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | Patients with non-small cell lung cancer carcinoma treated with erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 1 year after the last patient is enrolled
Secondary outcomes (2)
response( according to RECIST)
Measured: 3 month after the last patient is enrolled
quality of live ( measured by EORTC PAL 15)
Measured: 3 month after the last patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, The Ministry of Science, Technology and Innovation, Denmark, Hoffmann-La Roche
- Investigators
- Peter Meldgaard, PhD MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815971
- Sponsor's protocol ID
- M-20080012 (ethics committee)
- Status last verified
- Dec 2008
- First submitted
- 30 Dec 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorensen BS, Wu L, Wei W, Tsai J, Weber B, Nexo E, Meldgaard P. Monitoring of epidermal growth factor receptor tyrosine kinase inhibitor-sensitizing and resistance mutations in the plasma DNA of patients with advanced non-small cell lung cancer during treatment with erlotinib. Cancer. 2014 Dec 15;120(24):3896-901. doi: 10.1002/cncr.28964. Epub 2014 Aug 7.
PubMed 25103305Weber B, Meldgaard P, Hager H, Wu L, Wei W, Tsai J, Khalil A, Nexo E, Sorensen BS. Detection of EGFR mutations in plasma and biopsies from non-small cell lung cancer patients by allele-specific PCR assays. BMC Cancer. 2014 Apr 28;14:294. doi: 10.1186/1471-2407-14-294.
PubMed 24773774
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib
- ClinicalTrials.gov ID
- NCT00815971
- Acronym / sponsor ID
- M-20080012 (ethics committee)
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR mutations, EGFR inhibitor, erlotinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, The Ministry of Science, Technology and Innovation, Denmark, Hoffmann-La Roche
- Study start
- May 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.
The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.
In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.
The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.
Detailed description
Aim:
- To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
- In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
- In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | –Patients with non-small cell lung cancer carcinoma treated with erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer who will start treatment with erlotinib
Key inclusion criteria (1 listed)
- Patients who are starting treatment with erlotinib and who has who has signed the informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 1 year after the last patient is enrolled
2 secondary outcomes
response( according to RECIST)
Time frame: 3 month after the last patient is enrolled
quality of live ( measured by EORTC PAL 15)
Time frame: 3 month after the last patient is enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Derived from this study: PubMed 25103305Sorensen BS, Wu L, Wei W, Tsai J, Weber B, Nexo E, Meldgaard P. Monitoring of epidermal growth factor receptor tyrosine kinase inhibitor-sensitizing and resistance mutations in the plasma DNA of patients with advanced non-small cell lung cancer during treatment with erlotinib. Cancer. 2014 Dec 15;120(24):3896-901. doi: 10.1002/cncr.28964. Epub 2014 Aug 7.
- Derived from this study: PubMed 24773774Weber B, Meldgaard P, Hager H, Wu L, Wei W, Tsai J, Khalil A, Nexo E, Sorensen BS. Detection of EGFR mutations in plasma and biopsies from non-small cell lung cancer patients by allele-specific PCR assays. BMC Cancer. 2014 Apr 28;14:294. doi: 10.1186/1471-2407-14-294.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Meldgaard, PhD MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Britta Weber, MD (+4589493333, doctorweber@stofanet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 1 year after the last patient is enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815971, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2008.