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| ID | Type | Description | Link |
|---|---|---|---|
| 09.214 | Other Identifier | CCTIRS |
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The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chemo-induced symptomatic anemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin biosimilar | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change and corrected Hemoglobin levels | Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Observe evolution of the biological indicators | Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation | 6 months |
| Study the profiles of treated patients |
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Inclusion Criteria:
Patients of more than 18 years of age
Patients presenting with anemia following chemotherapy
Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy
-- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
Patients eligible for epoetin alfa biosimilar treatment
Exclusion Criteria:
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Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agen | 47000 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25011615 | Derived | Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503. |
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| 6 months |
| Assess the reasons for the prescriber's treatment regimens | 6 months |
| Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics | 6 months |
| Observation of the safety profiles of the Product (Epoetin Alfa) | 6 months |
| Aix-en-Provence |
| 13100 |
| France |
| Aix-en-Provence | 13101 | France |
| Aix-en-Provence | 13616 | France |
| Ajaccio | 20176 | France |
| Albi | 81000 | France |
| Amboise | 37400 | France |
| Amilly | 45200 | France |
| Annecy | 74000 | France |
| Antibes | 6606 | France |
| Armentières | 59421 | France |
| Arras | 62000 | France |
| Arras | 62022 | France |
| Aulnay-sous-Bois | 93602 | France |
| Avignon | 84000 | France |
| Avignon | 84082 | France |
| Bayonne | 64100 | France |
| Beauvais | 60021 | France |
| Besançon | 25030 | France |
| Beuvry | 62660 | France |
| Béthune | 62400 | France |
| Béziers | 34500 | France |
| Blois | 41000 | France |
| Bois-Guillaume | 76230 | France |
| Bordeaux | 33000 | France |
| Bordeaux | 33076 | France |
| Bordeaux | 33300 | France |
| Boulogne-sur-Mer | 62200 | France |
| Brest | 29200 | France |
| Brest | 29609 | France |
| Bron | 69500 | France |
| Caen | 14000 | France |
| Caen | 14033 | France |
| Cannes | 6401 | France |
| Cannes | 6414 | France |
| Carcassonne | 11000 | France |
| Carcassonne | 11890 | France |
| Castelnau-le-Lez | 34170 | France |
| Challes-les-Eaux | 73190 | France |
| Chalon/saonne | 71321 | France |
| Chambéry | 73000 | France |
| Chambéry | 73011 | France |
| Cherbourg-octeville | 50100 | France |
| Clermont-Ferrand | 63011 | France |
| Colmar | 68000 | France |
| Colmar | 68024 | France |
| Compiègne | 60321 | France |
| Créteil | 94000 | France |
| Croix | 59963 | France |
| Désertines | 3630 | France |
| Dijon | 21079 | France |
| Draguignan | 83007 | France |
| Draguignan | 83300 | France |
| Dunkirk | 59240 | France |
| Évreux | 27025 | France |
| Feurs | 42110 | France |
| Foix | 9017 | France |
| Freyming-Merlebach | 57804 | France |
| Fréjus | 83600 | France |
| Fréjus | 83608 | France |
| Fryming Merle BACH | 57800 | France |
| Gap | 5000 | France |
| Gap | 5007 | France |
| Grasse | 6135 | France |
| Haguenau | 67500 | France |
| Hyères | 83056 | France |
| Hyères | 83400 | France |
| La Roche-sur-Yon | 85925 | France |
| La Rochelle | 17019 | France |
| La Seyne-sur-Mer | 83500 | France |
| La Tronche | 38700 | France |
| Le Blanc-Mesnil | 93150 | France |
| Le Mans | 72037 | France |
| Lille | 59000 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Lyon | 69000 | France |
| Lyon | 69365 | France |
| Lyon | 69373 | France |
| Lyon | 69424 | France |
| Lyon | 69437 | France |
| Mareuil LES MAUX | 77100 | France |
| Marseille | 13004 | France |
| Marseille | 13005 | France |
| Marseille | 13006 | France |
| Marseille | 13008 | France |
| Marseille | 13009 | France |
| Marseille | 13012 | France |
| Marseille | 13015 | France |
| Marseille | 13285 | France |
| Marseille | 13385 | France |
| Marseille | 13915 | France |
| Mâcon | 71018 | France |
| Meaux | 77100 | France |
| Metz | 57038 | France |
| Metz | 57077 | France |
| Monaco | 98012 | France |
| Mont-de-Marsan | 40024 | France |
| Montargis | 45207 | France |
| Montauban | 82013 | France |
| Montbéliard | 25200 | France |
| Montbéliard | 25209 | France |
| Montfermeil | 93370 | France |
| Montpellier | 34090 | France |
| Montpellier | 34295 | France |
| Morlaix | 29600 | France |
| Moulins | 3006 | France |
| Mulhouse | 68051 | France |
| Mulhouse | 68067 | France |
| Mulhouse | 68070 | France |
| Nancy | 54100 | France |
| Nantes | 44093 | France |
| Nantes Saint Herblain | 44805 | France |
| Narbonne | 11100 | France |
| Nice | 6000 | France |
| Nice | 6189 | France |
| Nice | 6202 | France |
| Niort | 79021 | France |
| Nîmes | 30029 | France |
| Nîmes | 30900 | France |
| Nogent/Marne | 94130 | France |
| Orléans | 45067 | France |
| Paris | 75004 | France |
| Paris | 75007 | France |
| Paris | 75014 | France |
| Paris | 75018 | France |
| Paris | 75116 | France |
| Perpignan | 66046 | France |
| Pessac | 33604 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86021 | France |
| Pontoise | 95300 | France |
| Pringy | 74370 | France |
| Pringy | 74374 | France |
| Reims | 51100 | France |
| Rennes | 35033 | France |
| Rouen | 76000 | France |
| Rouen | 76044 | France |
| Rouen | 76100 | France |
| Saint-Cloud | 92210 | France |
| Saint-Gaudens | 31800 | France |
| Saint-Germain-en-Laye | 78015 | France |
| Saint-Germain-en-Laye | 78100 | France |
| Saint-Herblain | 44805 | France |
| Saint-Priest-en-Jarez | 42227 | France |
| Saint-Quentin | 02321 | France |
| Sainte-Feyre | 23000 | France |
| Sélestat | 67604 | France |
| Strasbourg | 67000 | France |
| Strasbourg | 67065 | France |
| Strasbourg | 67091 | France |
| Strasbourg | 67098 | France |
| Strasbourg | 67100 | France |
| Talence | 33401 | France |
| Tarbes | 65000 | France |
| Thionville | 57100 | France |
| Thonon-les-Bains | 74203 | France |
| Toulon | 83041 | France |
| Toulon | 83056 | France |
| Toulon | 83100 | France |
| Toulouse | 31059 | France |
| Toulouse | 31076 | France |
| Tours | 37044 | France |
| Tremblay-en-France | 93290 | France |
| Troyes | 10003 | France |
| Valence | 26953 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Versailles | 78000 | France |
| Vénissieux | 69200 | France |
| Vichy | 3201 | France |
| Villefranche/saone | 69655 | France |
| Villeneuve-sur-Lot | 47307 | France |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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