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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in France

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

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 groups in NCT01167972
Study groupRoleWhat they receive
1Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx).

    Measured: 12 months / At each visit

  2. Describe the therapeutic management of patients with EGFR M +.

    Measured: 12 months / At each visit

  3. 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.

  1. First posted22 Jul 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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)
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

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.

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