NCT01956331

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

4.3 years

First QC Date

September 29, 2013

Last Update Submit

October 6, 2013

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSC lung Cancer,Elderly patients,post operative,

Outcome Measures

Primary Outcomes (1)

  • Post operative morbidity à 30-day

    Post operative morbidity at 30-day : Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0. Complications grade 2.3.4 will be analyzed from day 1 up to day 30, collected at Day 1,Day 10, Day 30. A data collection is scheduled at Day 90 for delayed complications. Evaluation : preoperative at Day-30 up to Day 0, Postoperative at Day 10, day 30, Day 90, Day 360.

    March 2014

Secondary Outcomes (3)

  • Post operative mortality

    March 2014

  • Length of post operative hospital stay

    March 2014

  • Length of intensive care unit stay

    March 2014

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients aged 70 years and more with Non Small Cell lung Cancer.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Centre Hospitalier D Argenteuil

Argenteuil, Val D'oise, 95100, France

Location

Site 12

Aix-en-Provence, 13100, France

Location

Centre Hospitalier Universitaire

Angers, 49033, France

Location

Centre Hospitalier du Morvan

Brest, 29200, France

Location

Centre François Baclesse

Caen, 14000, France

Location

Centre Hospitalier René Dubos

Cergy-Pontoise, 95301, France

Location

Site 30

Charleville-Mézières, 08000, France

Location

Site 33

Créteil, 94010, France

Location

Site 07

Draguignan, 83300, France

Location

Site 32

Elbeuf, 76503, France

Location

Site 04

Gap, 05000, France

Location

Centre Hospitalier Les Oudairies

La Roche-sur-Yon, 85000, France

Location

Site 41

Le Chesnay, 78157, France

Location

Hospital du Cluzeau

Limoges, 87042, France

Location

Centre Hospitalier Régional

Longjumeau, 91160, France

Location

Site 06

Marseille, 13274, France

Location

Site 42

Orléans, 45032, France

Location

Hospital Saint Antoine

Paris, 75012, France

Location

Site 19

Périgueux, 24019, France

Location

Site 20

Rennes, 35033, France

Location

Site 18

Rouen, 76031, France

Location

Site 17

Rouen, 76233, France

Location

Hôpital Yves Le Foll

Saint-Brieuc, 22023, France

Location

Site 14

Toulon, 83800, France

Location

Site 11

Villefranche-sur-Saône, 69655, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • LECAER HERVE, MD

    HOPITAL DE DRAGUIGNAN - SERVICE DE PNEUMOLOGIE

    STUDY DIRECTOR

  • CHOUAID CHRISTOS, PR

    HOPITAL INTERCOMMUNAL DE CRETEIL SERVICE DE PNEUMOLOGIE

    STUDY DIRECTOR

  • RAYNAUD Christine, MD

    CENTRE HOSPITALIER D'ARGENTEUIL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 8, 2013

Study Start

March 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

FR(25)