Non-small Cell Lung CancerNCT01721252
Tarceva. ICORG 08-41
An observational study of Non-small Cell Lung Cancer, run by Cancer Trials Ireland at 7 sites in Ireland.
Trial summary
The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy. 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
- 200 participants
- Where
- 7 sitesIreland
- Study dates
- Dec 2009to Aug 2013
- 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: Any patient (18 years of age or older) diagnosed with non-small cell lung cancer at any stage who is to be treated with erlotinib.
Who may be able to join
- 18 years of age or older
- Any patient who is suited to receive CT scans as part of his/her routine care
- Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures
- Planned treatment with erlotinib.
Who cannot join
- Patients younger than 18 years of age
- Patients not foreseen to receive TarcevaTM treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Ireland7 sites
Cork University Hospital
Cork
Beaumont Hospital
Dublin
St James Hospital
Dublin
The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
Dublin
Galway University Hospital
Galway
Mid-Western Regional Hospital
Limerick
Our Lady Of Lourdes Hospital, Drogheda
Louth
About this study
Official title: Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer
The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy.
This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.
Read the detailed description
Screening/Baseline
- Routine blood tests (Haematology and Biochemistry) as per hospital practice
- Research serum sample for proteomic studies (10ml blood sample)
- Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size
2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
1 year Post Commencement of Treatment with erlotinib (as per current standard of care): Routine CT with RECIST/WHO assessment
Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
Follow Up: Subsequent follow-up as per routine.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, Erlotinib, TarcevaTM, proteomic signature
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of a recently identified proteomic algorithm
Routine CT with RECIST/WHO assessment
Measured: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startDec 2009
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721252
- Sponsor's protocol ID
- ICORG 08-41
- Status last verified
- Mar 2015
- First submitted
- 24 Oct 2012
- Last updated
- 30 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01721252
- Acronym / sponsor ID
- ICORG 08-41
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, Erlotinib, TarcevaTM, proteomic signature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Dec 2009
- Primary completion
- Aug 2013 (actual)
- First posted
- 5 Nov 2012 (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.
The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy.
This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.
Detailed description
Screening/Baseline
- Routine blood tests (Haematology and Biochemistry) as per hospital practice
- Research serum sample for proteomic studies (10ml blood sample)
- Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size
2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
1 year Post Commencement of Treatment with erlotinib (as per current standard of care): Routine CT with RECIST/WHO assessment
Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
Follow Up: Subsequent follow-up as per routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient (18 years of age or older) diagnosed with non-small cell lung cancer at any stage who is to be treated with erlotinib.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Any patient who is suited to receive CT scans as part of his/her routine care
- Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures
- Planned treatment with erlotinib.
Key exclusion criteria (2 listed)
- Patients younger than 18 years of age
- Patients not foreseen to receive TarcevaTM treatment
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
Value of a recently identified proteomic algorithm
Time frame: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
Routine CT with RECIST/WHO assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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 Cancer Trials Ireland at 7 sites in Ireland.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of a recently identified proteomic algorithm (time frame: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2015.