Observational Study on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma

NCT01167972 | Completed

• 1 other identifier: NIS-OFR-DUM-2010/1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 101

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma

  At baseline

Secondary Outcomes (3)

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

  12 months / At each visit

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

  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

  12 months / At each visit

Study Arms (1)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Assessment of mutational status of EGFR is not done

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (101)

Research Site

Abbeville, France

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Aix-en-Provence, France

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Amilly, France

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Angers, France

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Antibes, France

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Arras, France

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Aulnay-sous-Bois, France

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Auxerre, France

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Bastia, France

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Bayonne, France

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Béthune, France

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Blois, France

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Bobigny, France

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Bois-Guillaume, France

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Bonneville, France

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Bordeaux, France

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Boulogne-sur-Mer, France

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Bourg-en-Bresse, France

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Brest, France

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Brive-la-Gaillarde, France

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Bron, France

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Caen, France

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Chalon-sur-Saône, France

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Chauny, France

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Clermont-Ferrand, France

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Colmar, France

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Compiègne, France

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Creil, France

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Créteil, France

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Dijon, France

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Douai, France

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Draguignan, France

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Fougères, France

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Gap, France

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Granville, France

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La Roche-sur-Yon, France

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La Rochelle, France

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La Seyne-sur-Mer, France

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La Source, France

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La Tronche, France

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Le Plessis-Robinson, France

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Lens, France

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Levallois-Perret, France

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Libourne, France

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Liévin, France

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Lille, France

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Limoges, France

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Longjumeau, France

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Lyon, France

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Mantes-la-Jolie, France

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Marseille, France

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Meaux, France

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Mont-de-Marsan, France

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Mont-Saint-Martin, France

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Montauban, France

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Montivilliers, France

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Montpellier, France

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Moulins, France

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Nevers, France

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Niort, France

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Nîmes, France

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Oloron-Sainte-Marie, France

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Paris, France

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Pau, France

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Pessac, France

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Pierre-Bénite, France

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Poitiers, France

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Pontivy, France

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Pontoise, France

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Pringy, France

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Privas, France

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Redon, France

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Reims, France

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Rennes, France

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Roanne, France

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Rouen, France

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Saint-Aubin-lès-Elbeuf, France

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Saint-Brieuc, France

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Saint-Denis, France

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Saint-Herblain, France

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Saint-Pierre-des-Corps, France

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Saint-Priest-en-Jarez, France

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Saint-Quentin, France

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Saintes, France

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Salouël, France

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Sarrebourg, France

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Soissons, France

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Ste Clotilde, France

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Ste Feyre, France

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Strasbourg, France

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Toulon, France

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Toulouse, France

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Tourcoing, France

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Tours, France

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Trappes, France

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Valence, France

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Vendôme, France

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Verdun, France

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Villejuif, France

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Villenave-d'Ornon, France

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Yerres, France

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Corrine Bernaud, Medical Director

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

FR (101)