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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital Anxiety and Depression scale (HAD) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Clinical Characteristics | 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 | At inclusion, 6 and 12 months after inclusion and every year up to 5 years | |
| EORTC QLQ-LC13 | at inclusion, 6 and 12 months after inclusion and every year up to 5 years | |
| Hospital Anxiety and Depression Scale (HAD) | at inclusion, 6 and 12 months after inclusion and every year up to 5 years | |
| Treatment characteristics | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice MOGENET | Contact | +33 (0)4 73 98 39 86 | Alice.MOGENET@ap-hm.fr | |
| Soizic FERLANDIN | Contact | +33 (0)663224789 | soizic_ferlandin@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Lionel FALCHERO | GFPC | Principal Investigator |
| Laurence BIGAY-GAME | GFPC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH du Pays d Aix | Recruiting | Aix-en-Provence | 13616 | France |
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|
| Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13) | Behavioral | 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) | Behavioral | 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. |
|
| At Baseline visit and up to 5 years |
| Overall Survival (OS) |
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 |
| CHU Angers | Not yet recruiting | Angers | 49033 | France |
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| Hôpital Henri Duffaut | Recruiting | Avignon | 84000 | France |
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| CH Bastia | Not yet recruiting | Bastia | 20200 | France |
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| APHP Hôpital Avicennes | Recruiting | Bobigny | 93000 | France |
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| CHU Morvan | Recruiting | Brest | 29200 | France |
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| Hôpital Louis Pradel | Not yet recruiting | Bron | 69500 | France |
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| Pneumologie Centre François Baclesse | Not yet recruiting | Caen | 14000 | France |
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| Centre Hospitalier du Cotentin | Recruiting | Cherbourg | 50102 | France |
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| CHU Hôpital Montpied | Recruiting | Clermont-Ferrand | 63000 | France |
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| Oncologie CLCC Jean Perrin | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Pneumologie Hospices Civils de Colmar | Recruiting | Colmar | 68024 | France |
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| Pneumologie Centre Hospitalier Intercommunal de Créteil | Recruiting | Créteil | 94010 | France |
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| Centre Hospitalier d'Elbeuf - Pneumologie | Recruiting | Elbeuf | 76503 | France |
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| CH Eure-Seine | Recruiting | Évreux | 27015 | France |
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| Grand Hôpital de l'Est Francilien - Site Marne la Vallée | Recruiting | Jossigny | 77600 | France |
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| Centre Hospitalier Les Oudairies | Recruiting | La Roche-sur-Yon | 85000 | France |
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| CH La Rochelle | Recruiting | La Rochelle | 17000 | France |
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| Hôpital Robert Boulin | Recruiting | Libourne | 33505 | France |
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| Hôpital de la Vallée | Recruiting | Longjumeau | 91160 | France |
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| Hôpital du Scorff | Recruiting | Lorient | 56100 | France |
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| Pneumologie Hôpital privé Jean Mermoz | Not yet recruiting | Lyon | 69085 | France |
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| Centre Léon Bérard | Not yet recruiting | Lyon | 69373 | France |
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| Hôpital Européen | Not yet recruiting | Marseille | 130003 | France |
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| Hôpital Nord - Oncologie Thoracique | Recruiting | Marseille | France |
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| GHEF Site de Meaux | Recruiting | Meaux | 77100 | France |
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| CHRU de Nancy | Not yet recruiting | Nancy | 54000 | France |
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| CHU Nantes | Not yet recruiting | Nantes | 44000 | France |
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| Pneumologie Hôpital Cochin | Not yet recruiting | Paris | 75014 | France |
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| Hôpital Tenon | Not yet recruiting | Paris | 75020 | France |
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| Hôpital La Pitié-Salpêtrière | Recruiting | Paris | 75651 | France |
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| Pneumologie Centre Hospitalier | Recruiting | Pau | 64000 | France |
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| Centre Catalan d'Oncologie | Recruiting | Perpignan | 66000 | France |
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| CHU Reims Hôpital Maison Blanche | Not yet recruiting | Reims | 51000 | France |
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| CHU Hôpital Ponchailloux | Recruiting | Rennes | 35033 | France |
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| Hôpital Charles Nicolle | Not yet recruiting | Rouen | 76031 | France |
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| Hôpital Privé de la Loire | Recruiting | Saint-Etienne | 42000 | France |
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| Pneumologie CHU St Etienne | Recruiting | Saint-Etienne | 42270 | France |
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| CH des Vallées de l'Ariège | Recruiting | Saint-Jean-de-Verges | 09000 | France |
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| CHU La Réunion Site Sud | Not yet recruiting | Saint-Pierre | 97410 | France |
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| CHU La Réunion Site Sud | Recruiting | Saint-Pierre | 97410 | France |
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| CH de Saint Malo | Recruiting | St-Malo | 35000 | France |
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| Hôpital d'Instruction des Armées Saint-Anne | Recruiting | Toulon | 83041 | France |
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| Hôpital Larrey | Recruiting | Toulouse | 31059 | France |
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| Oncologie CH Bretagne-Atlantique | Recruiting | Vannes | 56000 | France |
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| Centre Hospitalier de Villefranche sur Saone | Recruiting | Villefranche-sur-Saône | 69655 | France |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
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