Non Small Cell Lung CancerMUTACTNCT01167972
Observational Study on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 101 sites in France.
Trial summary
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma. 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
- 2,000 participants
- Where
- 101 sitesFrance
- Study dates
- Sep 2010to Sep 2012
- 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: Patient with NSCLC adenocarcinoma confirmed by histologyPatient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed
Who may be able to join
- Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma)
- Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed
Who cannot join
- Assessment of mutational status of EGFR is not done
Trial locations and contacts
101 sites in 1 country.
101 sites in 1 country
France101 sites
Research Site
Abbeville
Research Site
Aix-en-Provence
Research Site
Amilly
Research Site
Angers
Research Site
Antibes
Research Site
Arras
Research Site
Aulnay-sous-Bois
Research Site
Auxerre
Research Site
Bastia
Research Site
Bayonne
Research Site
Béthune
Research Site
Blois
Research Site
Bobigny
Research Site
Bois-Guillaume
Research Site
Bonneville
Research Site
Bordeaux
Research Site
Boulogne-sur-Mer
Research Site
Bourg-en-Bresse
Research Site
Brest
Research Site
Brive-la-Gaillarde
Research Site
Bron
Research Site
Caen
Research Site
Chalon-sur-Saône
Research Site
Chauny
Research Site
Clermont-Ferrand
Research Site
Colmar
Research Site
Compiègne
Research Site
Creil
Research Site
Créteil
Research Site
Dijon
Research Site
Douai
Research Site
Draguignan
Research Site
Fougères
Research Site
Gap
Research Site
Granville
Research Site
La Roche-sur-Yon
Research Site
La Rochelle
Research Site
La Seyne-sur-Mer
Research Site
La Source
Research Site
La Tronche
Research Site
Le Plessis-Robinson
Research Site
Lens
Research Site
Levallois-Perret
Research Site
Libourne
Research Site
Liévin
Research Site
Lille
Research Site
Limoges
Research Site
Longjumeau
Research Site
Lyon
Research Site
Mantes-la-Jolie
Research Site
Marseille
Research Site
Meaux
Research Site
Mont-de-Marsan
Research Site
Mont-Saint-Martin
Research Site
Montauban
Research Site
Montivilliers
Research Site
Montpellier
Research Site
Moulins
Research Site
Nevers
Research Site
Nîmes
Research Site
Niort
Research Site
Oloron-Sainte-Marie
Research Site
Paris
Research Site
Pau
Research Site
Pessac
Research Site
Pierre-Bénite
Research Site
Poitiers
Research Site
Pontivy
Research Site
Pontoise
Research Site
Pringy
Research Site
Privas
Research Site
Redon
Research Site
Reims
Research Site
Rennes
Research Site
Roanne
Research Site
Rouen
Research Site
Saint-Aubin-lès-Elbeuf
Research Site
Saint-Brieuc
Research Site
Saint-Denis
Research Site
Saint-Herblain
Research Site
Saint-Pierre-des-Corps
Research Site
Saint-Priest-en-Jarez
Research Site
Saint-Quentin
Research Site
Saintes
Research Site
Salouël
Research Site
Sarrebourg
Research Site
Soissons
Research Site
Ste Clotilde
Research Site
Ste Feyre
Research Site
Strasbourg
Research Site
Toulon
Research Site
Toulouse
Research Site
Tourcoing
Research Site
Tours
Research Site
Trappes
Research Site
Valence
Research Site
Vendôme
Research Site
Verdun
Research Site
Villejuif
Research Site
Villenave-d'Ornon
Research Site
Yerres
About this study
Official title: Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.
Read the detailed description
MSD
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- M + mutation, Non Small Cell Lung Cancer adenocarcinoma, To determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
- 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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
Measured: At baseline
Secondary outcomes (3)
Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx).
Measured: 12 months / At each visit
Describe the therapeutic management of patients with EGFR M +.
Measured: 12 months / At each visit
Describe the clinical course of patients EGFR-M +, treated for first-line treatment, and then 2nd line treatment, until 31-AUG-2012
Measured: 12 months / At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
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.
- More trials run by AstraZenecaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corrine Bernaud, Medical Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167972
- Sponsor's protocol ID
- NIS-OFR-DUM-2010/1
- Acronym
- MUTACT
- Status last verified
- Sep 2012
- First submitted
- 20 Jul 2010
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)
- ClinicalTrials.gov ID
- NCT01167972
- Acronym / sponsor ID
- MUTACT / NIS-OFR-DUM-2010/1
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- M + mutation, Non Small Cell Lung Cancer adenocarcinoma, To determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jul 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.
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.
Detailed description
MSD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with NSCLC adenocarcinoma confirmed by histologyPatient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed
Key inclusion criteria (2 listed)
- Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma)
- Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed
Key exclusion criteria (1 listed)
- Assessment of mutational status of EGFR is not done
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
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
Time frame: At baseline
3 secondary outcomes
Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx).
Time frame: 12 months / At each visit
Describe the therapeutic management of patients with EGFR M +.
Time frame: 12 months / At each visit
Describe the clinical course of patients EGFR-M +, treated for first-line treatment, and then 2nd line treatment, until 31-AUG-2012
Time frame: 12 months / At each visit
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 10 Sep 2012.
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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.
Corrine Bernaud, Medical Director study director
AstraZeneca
101 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 AstraZeneca at 101 sites in France.
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 2 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in France. 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?
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma (time frame: At baseline). 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 10 Sep 2012.