Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (Lungevity Study)
NCT ID: NCT07243132
Last Updated: 2025-11-25
Study Results
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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RECRUITING
1000 participants
OBSERVATIONAL
2025-07-02
2031-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Hospital Anxiety and Depression scale (HAD)
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).
Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13)
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.
Questionnaire Aix-Marseille-Université (AMU)
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.
Interventions
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Hospital Anxiety and Depression scale (HAD)
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).
Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13)
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.
Questionnaire Aix-Marseille-Université (AMU)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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GFPC Investigation
OTHER
Responsible Party
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Principal Investigators
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Lionel FALCHERO
Role: PRINCIPAL_INVESTIGATOR
GFPC
Laurence BIGAY-GAME
Role: PRINCIPAL_INVESTIGATOR
GFPC
Locations
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CH du Pays d Aix
Aix-en-Provence, , France
CHU Angers
Angers, , France
Hôpital Henri Duffaut
Avignon, , France
CH Bastia
Bastia, , France
APHP Hôpital Avicennes
Bobigny, , France
CHU Morvan
Brest, , France
Hôpital Louis Pradel
Bron, , France
Pneumologie Centre François Baclesse
Caen, , France
Centre Hospitalier du Cotentin
Cherbourg, , France
CHU Hôpital Montpied
Clermont-Ferrand, , France
Oncologie CLCC Jean Perrin
Clermont-Ferrand, , France
Pneumologie Hospices Civils de Colmar
Colmar, , France
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Centre Hospitalier d'Elbeuf - Pneumologie
Elbeuf, , France
CH Eure-Seine
Évreux, , France
Grand Hôpital de l'Est Francilien - Site Marne la Vallée
Jossigny, , France
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, , France
CH La Rochelle
La Rochelle, , France
Hôpital Robert Boulin
Libourne, , France
Hôpital de la Vallée
Longjumeau, , France
Hôpital du Scorff
Lorient, , France
Pneumologie Hôpital privé Jean Mermoz
Lyon, , France
Centre Léon Bérard
Lyon, , France
Hôpital Européen
Marseille, , France
Hôpital Nord - Oncologie Thoracique
Marseille, , France
GHEF Site de Meaux
Meaux, , France
CHRU de Nancy
Nancy, , France
CHU Nantes
Nantes, , France
Pneumologie Hôpital Cochin
Paris, , France
Hôpital Tenon
Paris, , France
Hôpital La Pitié-Salpêtrière
Paris, , France
Pneumologie Centre Hospitalier
Pau, , France
Centre Catalan d'Oncologie
Perpignan, , France
CHU Reims Hôpital Maison Blanche
Reims, , France
CHU Hôpital Ponchailloux
Rennes, , France
Hôpital Charles Nicolle
Rouen, , France
Hôpital Privé de la Loire
Saint-Etienne, , France
Pneumologie CHU St Etienne
Saint-Etienne, , France
CH des Vallées de l'Ariège
Saint-Jean-de-Verges, , France
CHU La Réunion Site Sud
Saint-Pierre, , France
CHU La Réunion Site Sud
Saint-Pierre, , France
CH de Saint Malo
St-Malo, , France
Hôpital d'Instruction des Armées Saint-Anne
Toulon, , France
Hôpital Larrey
Toulouse, , France
Oncologie CH Bretagne-Atlantique
Vannes, , France
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GFPC INVESTIGATION 07-2019
Identifier Type: -
Identifier Source: org_study_id
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