Mutations in Exons 18 to 21NCT01215474
Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC
An observational study of Mutations in Exons 18 to 21, run by Provitro GmbH at 1 site in Germany.
Trial summary
While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mutations in Exons 18 to 21
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were biopsied and/or received surgery for NSCLC diagnostics
Who may be able to join
- NSCLC Stadium III-IV
Who cannot join
- no NSCLC or different stadium
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Pathology, Charité University Medicine Berlin
Berlin, 10117
About this study
While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the above mentioned exons and correlate the results to the clinical outcome. This approach will enable us to potentially identify patients that might in the future benefit from targeted therapy (EGFR-inhibition).
- Conditions
- Mutations in Exons 18 to 21
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 Stadium III-IV | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mutations in Exons 18 to 21Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provitro GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215474
- Sponsor's protocol ID
- AZ-NSCLC 18+
- Status last verified
- Oct 2010
- First submitted
- 5 Oct 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC
- ClinicalTrials.gov ID
- NCT01215474
- Acronym / sponsor ID
- AZ-NSCLC 18+
- Conditions
- Mutations in Exons 18 to 21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Provitro GmbHIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca, Charite University, Berlin, Germany
- First posted
- 6 Oct 2010 (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.
While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the above mentioned exons and correlate the results to the clinical outcome. This approach will enable us to potentially identify patients that might in the future benefit from targeted therapy (EGFR-inhibition).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC Stadium III-IV | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were biopsied and/or received surgery for NSCLC diagnostics
Key inclusion criteria (1 listed)
- NSCLC Stadium III-IV
Key exclusion criteria (1 listed)
- no NSCLC or different stadium
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
Not reported in the source record.
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 16 Jun 2011.
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.
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 Mutations in Exons 18 to 21, run by Provitro GmbH at 1 site in Germany.
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: finished, as of the sponsor's last update on 16 Jun 2011. 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 Germany. 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.
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 16 Jun 2011.