Carcinoma, Non-Small-Cell LungOPERAGENCT01956331
Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Groupe Francais De Pneumo-Cancerologie at 25 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 302 participants
- Where
- 25 sitesFrance
- Study dates
- Mar 2009to Jun 2013
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients aged 70 years and more with Non Small Cell lung Cancer.
Who may be able to join
- Patient 70 years and more
- Lung tumour of clinical staging I to IIIB receiving curative lung resection
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Site 12
Aix-en-Provence, 13100
Centre Hospitalier Universitaire
Angers, 49033
Centre Hospitalier D Argenteuil
Argenteuil, Val D'oise, 95100
Centre Hospitalier du Morvan
Brest, 29200
Centre François Baclesse
Caen, 14000
Centre Hospitalier René Dubos
Cergy-Pontoise, 95301
Site 30
Charleville-Mézières, 08000
Site 33
Créteil, 94010
Site 07
Draguignan, 83300
Site 32
Elbeuf, 76503
Site 04
Gap, 05000
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, 85000
Site 41
Le Chesnay, 78157
Hospital du Cluzeau
Limoges, 87042
Centre Hospitalier Régional
Longjumeau, 91160
Site 06
Marseille, 13274
Site 42
Orléans, 45032
Hospital Saint Antoine
Paris, 75012
Site 19
Périgueux, 24019
Site 20
Rennes, 35033
Site 18
Rouen, 76031
Site 17
Rouen, 76233
Hôpital Yves Le Foll
Saint-Brieuc, 22023
Site 14
Toulon, 83800
Site 11
Villefranche-sur-Saône, 69655
About this study
Official title: Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer
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.
Read the detailed description
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
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSC lung Cancer,Elderly patients,post operative,
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: March 2014
Secondary outcomes (3)
Post operative mortality
Post operative mortality : mortality from Day 1 to Day 30 and survival at Day 360.
Quality of life will be evaluated by :
LCSS Spitzer index ADL,IADL.
Measured: March 2014
Length of post operative hospital stay
Length of post operative hospital stay : hospitalization duration : intensive care, surgery department evaluated at Day 10 and post operative visit Day 30.
Measured: March 2014
Length of intensive care unit stay
Length of intensive care unit stay evaluated at Day 10 (hospital release)and post operative visit at Day 30
Measured: March 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LECAER HERVE, MD, Study director, HOPITAL DE DRAGUIGNAN - SERVICE DE PNEUMOLOGIECHOUAID CHRISTOS, PR, Study director, HOPITAL INTERCOMMUNAL DE CRETEIL SERVICE DE PNEUMOLOGIERAYNAUD Christine, MD, Principal investigator, CENTRE HOSPITALIER D'ARGENTEUIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956331
- Sponsor's protocol ID
- GFPC 08-05
- Acronym
- OPERAGE
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer
- ClinicalTrials.gov ID
- NCT01956331
- Acronym / sponsor ID
- OPERAGE / GFPC 08-05
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSC lung Cancer,Elderly patients,post operative,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Oct 2013 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients aged 70 years and more with Non Small Cell lung Cancer.
Key inclusion criteria (2 listed)
- Patient 70 years and more
- Lung tumour of clinical staging I to IIIB receiving curative lung resection
Key exclusion criteria (3 listed)
- 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
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
Post operative morbidity à 30-day
Time frame: March 2014
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.
3 secondary outcomes
Post operative mortality
Time frame: March 2014
Length of post operative hospital stay
Time frame: March 2014
Length of intensive care unit stay
Time frame: March 2014
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 8 Oct 2013.
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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.
LECAER HERVE, MD study director
HOPITAL DE DRAGUIGNAN - SERVICE DE PNEUMOLOGIE
CHOUAID CHRISTOS, PR study director
HOPITAL INTERCOMMUNAL DE CRETEIL SERVICE DE PNEUMOLOGIE
RAYNAUD Christine, MD principal investigator
CENTRE HOSPITALIER D'ARGENTEUIL
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Groupe Francais De Pneumo-Cancerologie at 25 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 3 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 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
Post operative morbidity à 30-day (time frame: March 2014). 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 8 Oct 2013.