- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243132
Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (Lungevity Study) (LUNGEVITY)
Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (LUNGEVITY STUDY)
The goal of this observational study is to identify and describe the clinical characteristics, health status, socio-economic impacts and quality of life of patients alive for three years after diagnosis of metastatic Lung cancer and no longer receiving cytotoxic chemotherapy. The main question is to identify the needs of these patients in terms of health status (impact of cancer treatments, incidence of new diseases, cardiovascular, diabetes, second cancers), socio-economic aspects, quality of life and return to employment.
Participants will be asked to answer quality of life questionnaires at the time of inclusion and 6 and 12 months after inclusion and then, every year up to 5 years in this study.
They will be followed regularly, in consultations, according to the usual practices of the physicians in each participating center.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alice MOGENET
- Phone Number: +33 (0)4 73 98 39 86
- Email: Alice.MOGENET@ap-hm.fr
Study Contact Backup
- Name: Soizic FERLANDIN
- Phone Number: +33 (0)663224789
- Email: soizic_ferlandin@yahoo.fr
Study Locations
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-
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Aix-en-Provence, France, 13616
- Recruiting
- CH du Pays d Aix
-
Contact:
- Stéphanie MARTINEZ
- Email: smartinez@ch-aix.fr
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Angers, France, 49033
- Not yet recruiting
- CHU Angers
-
Contact:
- Youssef Oulkhouir
- Email: youssef.oulkhouir@chu-angers.fr
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Avignon, France, 84000
- Recruiting
- Hôpital Henri Duffaut
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Contact:
- Nicolas CLOAREC
- Email: clarec.nicolas@ch-avignon.fr
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Bastia, France, 20200
- Not yet recruiting
- CH Bastia
-
Contact:
- Pascal THOMAS
- Email: pascal.thomas@ch-bastia.fr
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Bobigny, France, 93000
- Recruiting
- APHP Hôpital Avicennes
-
Contact:
- Boris DUCHEMANN
- Email: boris.duchemann@aphp.fr
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Brest, France, 29200
- Recruiting
- CHU Morvan
-
Contact:
- Margaux Geier
- Email: margaux.geier@chu-brest.fr
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Bron, France, 69500
- Not yet recruiting
- Hôpital Louis Pradel
-
Contact:
- Thomas PIERRET
- Email: thomas.pierret@chu-lyon.fr
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Caen, France, 14000
- Not yet recruiting
- Pneumologie Centre François Baclesse
-
Contact:
- Hubert CURCIO
- Email: h.curcio@baclesse.unicncer.fr
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Cherbourg, France, 50102
- Recruiting
- Centre Hospitalier du Cotentin
-
Contact:
- Laure KALUZINSKI
- Email: l.kaluzinski@ch-cotentin.fr
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Clermont-Ferrand, France, 63000
- Not yet recruiting
- Oncologie CLCC Jean Perrin
-
Contact:
- Lise THIBONNIER
- Email: lise.thibonnier@clermont.unicancer.fr
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Clermont-Ferrand, France, 63000
- Recruiting
- CHU Hôpital Montpied
-
Contact:
- Patrick MERLE
- Email: pmerle@chu-clermontferrand.fr
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Colmar, France, 68024
- Recruiting
- Pneumologie Hospices Civils de Colmar
-
Contact:
- Lionel MOREAU
- Email: lionel.moreau@ch-colmar.fr
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Créteil, France, 94010
- Recruiting
- Pneumologie Centre Hospitalier Intercommunal de Créteil
-
Contact:
- Jean-Bernard AULIAC
- Email: jean-bernard.auliac@chicreteil.fr
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Elbeuf, France, 76503
- Recruiting
- Centre Hospitalier d'Elbeuf - Pneumologie
-
Contact:
- Pierre-Alexandre HAUSS
- Email: Pierre-Alexandre.Hauss@chi-elbeuf-louviers.fr
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Jossigny, France, 77600
- Recruiting
- Grand Hôpital de l'Est Francilien - Site Marne la Vallée
-
Contact:
- Tamar KUTATELADZE
- Email: tkutateladze@ghef.fr
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La Roche-sur-Yon, France, 85000
- Recruiting
- Centre Hospitalier Les Oudairies
-
Contact:
- Marie MARCQ, Doctor
- Phone Number: +33251446164
- Email: marie.marcq@ght85.fr
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La Rochelle, France, 17000
- Recruiting
- CH La Rochelle
-
Contact:
- Marion LAFARGE
- Email: marion.lafarge@ght-atlantique17.fr
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Libourne, France, 33505
- Recruiting
- Hôpital Robert Boulin
-
Contact:
- Menouar-Samir ABDICHE
- Email: menouar-samir.abdiche@ch-libourne.fr
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Longjumeau, France, 91160
- Recruiting
- Hôpital de la Vallée
-
Contact:
- Alain BEKEBE
- Email: a.bakebe@gh-nord-essonne.fr
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Lorient, France, 56100
- Recruiting
- Hôpital du Scorff
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Contact:
- Régine LAMY
- Email: r.lamy@ch-bretagne-sud.fr
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Lyon, France, 69373
- Not yet recruiting
- Centre Léon Bérard
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Contact:
- Romane GILLE
- Email: romane.gille@lyon.unicancer.fr
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Lyon, France, 69085
- Not yet recruiting
- Pneumologie Hôpital privé Jean Mermoz
-
Contact:
- Pierre BOMBARON
- Email: p.bombaron@orange.fr
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Marseille, France, 130003
- Not yet recruiting
- Hôpital Européen
-
Contact:
- Jacques LE TREUT
- Email: j.letreut@hopital-europeen.fr
-
Marseille, France
- Recruiting
- Hôpital Nord - Oncologie Thoracique
-
Contact:
- Alice MOGENET
- Email: alice.mogenet@ap-hm.fr
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Meaux, France, 77100
- Recruiting
- GHEF Site de Meaux
-
Contact:
- Chrystèle LOCHER
- Email: chlocher@ghef.fr
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Nancy, France, 54000
- Not yet recruiting
- CHRU de NANCY
-
Contact:
- Aurélie VILLEMAIN
- Email: a.villemain@chru-nancy.fr
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Nantes, France, 44000
- Not yet recruiting
- CHU Nantes
-
Contact:
- Elvire PONS TOSTIVINT
- Email: elvire.pons@chu-nantes.fr
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Paris, France, 75020
- Not yet recruiting
- Hopital Tenon
-
Contact:
- Vincent FALLET
- Phone Number: +33 (0)1 56 01 62 18
- Email: vincent.fallet@aphp.fr
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Paris, France, 75651
- Recruiting
- Hôpital La Pitié-Salpétrière
-
Contact:
- Baptiste ABBAR
- Email: baptiste.abbar@aphp.fr
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Paris, France, 75014
- Not yet recruiting
- Pneumologie Hôpital Cochin
-
Contact:
- Marie WISLEZ
- Email: marie.wislez@aphp.fr
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Pau, France, 64000
- Recruiting
- Pneumologie Centre Hospitalier
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Contact:
- Aldo RENAULT
- Email: also.renault@ch-pau.fr
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Perpignan, France, 66000
- Recruiting
- Centre Catalan d'Oncologie
-
Contact:
- Sabine VEILLIOT
- Email: sabinevieillot@gmail.com
-
Reims, France, 51000
- Not yet recruiting
- CHU Reims Hôpital Maison Blanche
-
Contact:
- Julien ANCEL
- Email: jancel@chu-nantes.fr
-
Rennes, France, 35033
- Recruiting
- CHU Hôpital Ponchailloux
-
Contact:
- Charles RICORDEL
- Email: charles.ricordel@chu-rennes.fr
-
Rouen, France, 76031
- Not yet recruiting
- Hopital Charles Nicolle
-
Contact:
- Florian GUISIER
- Email: florian.guisier@chu-rouen.fr
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Saint-Etienne, France, 42270
- Recruiting
- Pneumologie CHU St Etienne
-
Contact:
- Sophie BAYLE-BLEUEZ
- Email: sophie.bayle@chu-st-etienne.fr
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Saint-Etienne, France, 42000
- Recruiting
- Hôpital Privé de la Loire
-
Contact:
- Claire TISSOT
- Email: c.tissot@ramsaygds.fr
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Saint-Jean-de-Verges, France, 09000
- Recruiting
- CH des Vallées de l'Ariège
-
Contact:
- Eléonore SIMON
- Email: eleonore.simon@chi-val-ariege.fr
-
Saint-Pierre, France, 97410
- Recruiting
- CHU La Réunion Site Sud
-
Contact:
- Aurélie KIENLEN
- Email: aurelie.kienlen@chr-reunion.fr
-
Saint-Pierre, France, 97410
- Not yet recruiting
- CHU La Réunion Site Sud
-
Contact:
- Eric HUCHOT
- Email: eric.huchot@chr-reunion.fr
-
St-Malo, France, 35000
- Recruiting
- CH de Saint Malo
-
Contact:
- Fanny THEPAULT
- Email: f.thepault@ch-stmalo.fr
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Toulon, France, 83041
- Recruiting
- Hôpital d'Instruction des Armées Saint-Anne
-
Contact:
- Nicolas PALEIRON
- Email: npaleiron@vivaldi.net
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Toulouse, France, 31059
- Recruiting
- Hôpital Larrey
-
Contact:
- Laurence BIGAY-GAME
- Email: bigaygame.l@chu-toulouse.fr
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Vannes, France, 56000
- Recruiting
- Oncologie CH Bretagne-Atlantique
-
Contact:
- Gonzague DE CHABOT
- Email: gonzague.dechabot@ch-bretagne-atlantique.fr
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Villefranche-sur-Saône, France, 69655
- Recruiting
- Centre Hospitalier de Villefranche sur Saone
-
Contact:
- Lionel FALCHERO
- Phone Number: +33 4 74 09 27 23
- Email: LFalchero@lhopitalnordouest.fr
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Évreux, France, 27015
- Recruiting
- CH Eure-Seine
-
Contact:
- Nicolas DELBERGHE
- Email: nicolas.delberghe@ch-eureseine.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients will be recruited by GFPC centers which is a large French network of hospitals and clinics particularly active in pneumology and thoracic oncology centers participating in clinical research.
The principal investigator in each center will identify consecutive patients eligible for inclusion. Patients will be asked to confirm their consent for data collection.
Description
Inclusion Criteria:
- Patient over 18 years old
- Patients alive after more than three years from diagnosis with stage IV or Stage III NSCLC or SCLC, not treated with cytotoxic chemotherapy at the time of inclusion (the patient may be undergoing imunotherapy, targeted therapy or surveillance).
- Patients covered by the French National Health Insurance program or with thirdparty-payer health insurance
Exclusion Criteria:
- Difficulties for understanding French
- Patients undergoing treatment with cytotoxic chemotherapy
- Patients under legal guardianship, under curatorship or tutorship
- Insufficient cognitive capacity to answer questions
- Inability to obtain data collection (lost to follow-up, patient's refusal for data collection)
- Patients refusing the collection of their data (an information sheet will be provided)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Long-Terms Responders in metastatic Lung Cancer
Long-term responders defined as patients alive for three years after diagnosis of metastatic Lung cancer (NSCLC and SCLC) and not receiving cytotoxic chemotherapy at the time of inclusion.
|
The HAD scale is an instrument used to screen for anxiety and depressive disorders.
It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), giving two scores (maximum score for each = 21).
The EORTC QLQ-LC13: a 13-item lung cancer-specific questionnaire module supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials.
The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (cough, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Data analysis will be firstly descriptive in order to report on the quality of life of respondents.
Then, in a second stage, the factors associated with quality of life will be analyzed using linear or logistic regression models depending on the nature of the variable of interest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline Clinical Characteristics
Time Frame: At Baseline visit, on a maximum period of 12 months.
|
Metastatic Lung Cancer Long-Terms Responders clinical characteristics: baseline patient demographics, clinical and pathological characteristics (e.g.
age, medical history, comorbidities, past history of cancer, smoking status, NSCLC or SCLC characteristics)
|
At Baseline visit, on a maximum period of 12 months.
|
|
Aix-Marseille-University (AMU) questionnaire
Time Frame: At inclusion, 6 and 12 months after inclusion and every year up to 5 years
|
At inclusion, 6 and 12 months after inclusion and every year up to 5 years
|
|
|
EORTC QLQ-LC13
Time Frame: at inclusion, 6 and 12 months after inclusion and every year up to 5 years
|
at inclusion, 6 and 12 months after inclusion and every year up to 5 years
|
|
|
Hospital Anxiety and Depression Scale (HAD)
Time Frame: at inclusion, 6 and 12 months after inclusion and every year up to 5 years
|
at inclusion, 6 and 12 months after inclusion and every year up to 5 years
|
|
|
Treatment characteristics
Time Frame: From date of first lung cancer treatment administration up to 5 years
|
Treatment characteristics are defined by the type of treatment, the numbers of cycle and the duration of treatment.
|
From date of first lung cancer treatment administration up to 5 years
|
|
Health status
Time Frame: At Baseline visit and up to 5 years
|
Health status will be evaluated using Eastern Cooperative Oncology Group performance status (PS), and collecting data new diseases, cardiovascular, diabetes, second cancers
|
At Baseline visit and up to 5 years
|
|
Socio-demographic characteristics
Time Frame: At Baseline visit and up to 5 years
|
Socio-demographic characteristics will be evaluated based on the following data: professional, socio-family and socio-economic characteristics, education, family status, potential professional exposure(s)
|
At Baseline visit and up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression free survival (PFS)
Time Frame: From date of first lung cancer treatment administration up to 5 years
|
PFS is defined as the length of time during and after the treatment of cancer, that a patient lives with the disease but it does not get worse.
PFS will be assessed by local review, as per the current practice at site.
|
From date of first lung cancer treatment administration up to 5 years
|
|
Overall Survival (OS)
Time Frame: From date of first lung cancer treatment initiation up to 5 years
|
Overall Survival is defined as the length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive.
|
From date of first lung cancer treatment initiation up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lionel FALCHERO, GFPC
- Principal Investigator: Laurence BIGAY-GAME, GFPC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFPC INVESTIGATION 07-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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