Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

NCT ID: NCT01956331

Last Updated: 2013-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-06-30

Brief Summary

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schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.

Detailed Description

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Primary outcome :

Post-operative morbidity at 30-day :

Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0, and Complications grade 2.3.4 will be analyzed from day 1, at day 20 up to day 30.

Evaluation :

Pre operative : Day -30 to Day 0, Post operative : Day 10, Day 30, Day 90, Day 360.

Secondary outcome :

Post-operative mortality, Length of post operative hospital stay, Length of intensive care unit stay, QOL assessment, One year survival.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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NSC lung Cancer,Elderly patients,post operative,

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient 70 years and more
* Lung tumour of clinical staging I to IIIB receiving curative lung resection

Exclusion Criteria

* Diagnosis of non small lung cancer invalidated by the histological findings of the operative sample
* psychological conditions, social support or geographical conditions not allowing the study follow up
* Pre operative chemotherapy or radiotherapy
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LECAER HERVE, MD

Role: STUDY_DIRECTOR

HOPITAL DE DRAGUIGNAN - SERVICE DE PNEUMOLOGIE

CHOUAID CHRISTOS, PR

Role: STUDY_DIRECTOR

HOPITAL INTERCOMMUNAL DE CRETEIL SERVICE DE PNEUMOLOGIE

RAYNAUD Christine, MD

Role: PRINCIPAL_INVESTIGATOR

CENTRE HOSPITALIER D'ARGENTEUIL

Locations

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Centre Hospitalier D Argenteuil

Argenteuil, Val D'oise, France

Site Status

Site 12

Aix-en-Provence, , France

Site Status

Centre Hospitalier Universitaire

Angers, , France

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Centre Hospitalier du Morvan

Brest, , France

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Centre François Baclesse

Caen, , France

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Centre Hospitalier René Dubos

Cergy-Pontoise, , France

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Site 30

Charleville-Mézières, , France

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Site 33

Créteil, , France

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Site 07

Draguignan, , France

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Site 32

Elbeuf, , France

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Site 04

Gap, , France

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Centre Hospitalier Les Oudairies

La Roche-sur-Yon, , France

Site Status

Site 41

Le Chesnay, , France

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Hospital du Cluzeau

Limoges, , France

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Centre Hospitalier Régional

Longjumeau, , France

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Site 06

Marseille, , France

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Site 42

Orléans, , France

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Hospital Saint Antoine

Paris, , France

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Site 19

Périgueux, , France

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Site 20

Rennes, , France

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Site 18

Rouen, , France

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Site 17

Rouen, , France

Site Status

Hôpital Yves Le Foll

Saint-Brieuc, , France

Site Status

Site 14

Toulon, , France

Site Status

Site 11

Villefranche-sur-Saône, , France

Site Status

Countries

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France

Other Identifiers

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GFPC 08-05

Identifier Type: -

Identifier Source: org_study_id