Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT02158169
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2014-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia', 'timeFrame': 'Patients are included at the time of the epoetin alpha biosimilar treatment initiation for chemotherapy-induced anemia and followed up to 12 to 16 weeks', 'description': "The efficiency of epoetin alpha biosimilar will be assessed by the responders'rate according to European Society for Medical Oncology (ESMO) guidelines. This rate will be compared depending on the iron supplementation.\n\nThe safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation."}], 'secondaryOutcomes': [{'measure': 'Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia', 'timeFrame': 'Baseline visit'}, {'measure': 'Procedures for evaluating possible iron deficiency and iron supplementation', 'timeFrame': 'At 12 to 16 weeks from baseline or at the end of chemotherapy'}, {'measure': 'Impact of iron supplementation on the doses of Retacrit® used, and on treatment duration', 'timeFrame': 'At 12 to 16 weeks from baseline or at the end of chemotherapy'}, {'measure': 'Experience of patients treated with Retacrit®', 'timeFrame': 'At 12 to 16 weeks from baseline or at the end of chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Anemia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.', 'detailedDescription': 'This is a longitudinal, observational, prospective, multicentre, cohort study, conducted on a representative sample of public and/or private hospital-based oncologists and haematologists practicing in Metropolitan France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for whom the oncologist decides to initiate epoetin alpha biosimilar treatment (curative or prophylactic) will be asked to participate from treatment initiation (baseline visit) up to 12-16 weeks after inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, aged 18 years and older, seen by the oncologist or hematologist for chemotherapy.\n* Patients for whom the oncologist or hematologist has decided the initiation of an epoetin alpha biosimilar treatment (Retacrit®) for anemia.\n* Patients informed about the computer processing of their medical data and their right of access and correction.\n\nExclusion Criteria:\n\n* Patients with hemoglobin concentrations \\>11 g/dL.\n* Patients who have been transfused within the previous month.\n* Patients who are hypersensitive to erythropoietin or one of its excipients.\n* Patients participating or having participated in the previous month in a clinical trial in the field of anaemia in oncology.\n* Patients refusing to participate in the observational study.'}, 'identificationModule': {'nctId': 'NCT02158169', 'acronym': 'SYNERGY', 'briefTitle': 'Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hospira, now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation', 'orgStudyIdInfo': {'id': 'Synergy'}}, 'contactsLocationsModule': {'locations': [{'city': 'Colmar', 'state': 'Alsace', 'country': 'France', 'facility': 'Hopital Louis Pasteur', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'city': 'Mulhouse', 'state': 'Alsace', 'country': 'France', 'facility': 'CH Emile Muller', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'CAC Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'Chu Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Aix-les-Bains', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'MEDIPOLE', 'geoPoint': {'lat': 45.69173, 'lon': 5.90863}}, {'city': 'Annecy', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'CHRA', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Bourg-en-Bresse', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Clinique CONVERT', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Chambéry', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Ch Chambery', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Chu Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Valence', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Ch Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'city': 'Rennes', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Chu Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'CHU SUD', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Clinique St Laurent', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Grégoire', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Chp St Greg', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'city': 'St-Malo', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Ch St Malo', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'city': 'Chalon S/s', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'CHG William MOREY'}, {'city': 'Dijon', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'CHU du BOCAGE', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Meaux', 'state': 'Champagne', 'country': 'France', 'facility': 'Clinique St Faron', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'city': 'Reims', 'state': 'Champagne', 'country': 'France', 'facility': 'Cac Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Quentin', 'state': 'Champagne', 'country': 'France', 'facility': 'Hopital St Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'city': 'Troyes', 'state': 'Champagne', 'country': 'France', 'facility': 'Hopital Troyes', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'city': 'Évreux', 'state': 'Haute Normandie', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'city': 'Montivilliers', 'state': 'Haute Normandie', 'country': 'France', 'facility': 'CH Jacques Monod', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}, {'city': 'Alès', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHG', 'geoPoint': {'lat': 44.12489, 'lon': 4.08082}}, {'city': 'Carcassonne', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHG', 'geoPoint': {'lat': 43.21649, 'lon': 2.34863}}, {'city': 'Montpellier', 'state': 'Languedoc', 'country': 'France', 'facility': 'Chu St Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nîmes', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Aix-en-Provence', 'state': 'Marseille', 'country': 'France', 'facility': "Ch Du Pays D'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Aix-en-Provence', 'state': 'Marseille', 'country': 'France', 'facility': 'Clinique Rambot', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Avignon', 'state': 'Marseille', 'country': 'France', 'facility': 'Ch Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Chu Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Fondation Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Hopital A.Pare', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'IPC', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Clermont', 'state': 'Massif Central', 'country': 'France', 'facility': 'Chu Estaing', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Clermont', 'state': 'Massif Central', 'country': 'France', 'facility': 'Chu Gabriel Montpied', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Clermont', 'state': 'Massif Central', 'country': 'France', 'facility': 'Pole Sante Republique', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Montluçon', 'state': 'Massif Central', 'country': 'France', 'facility': 'Clinique Vitalia Desertines', 'geoPoint': {'lat': 46.34015, 'lon': 2.60254}}, {'city': 'Roanne', 'state': 'Massif Central', 'country': 'France', 'facility': 'CHR', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}, {'city': 'Saint-Etienne', 'state': 'Massif Central', 'country': 'France', 'facility': 'Icl St Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Cahors', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'CHG Cahors', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'city': 'Saint-Gaudens', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'CHG St Gaudens', 'geoPoint': {'lat': 43.10813, 'lon': 0.72318}}, {'city': 'Tarbes', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': "Clinique de l'Ormeau", 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'city': 'Toulouse', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'CHU Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'Inst. Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Arras', 'state': 'Nord', 'country': 'France', 'facility': 'Clinique des Bonnettes', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'city': 'Boulogne', 'state': 'Nord', 'country': 'France', 'facility': 'CH Boulogne-sur-Mer', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Valenciennes', 'state': 'Nord', 'country': 'France', 'facility': 'Clinique des Dentellieres', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'city': 'Fréjus', 'state': 'Paca', 'country': 'France', 'facility': 'Chi Frejus - St Raphael', 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'city': 'Nice', 'state': 'Paca', 'country': 'France', 'facility': 'Clinique Belvédère', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Toulon', 'state': 'Paca', 'country': 'France', 'facility': 'CH Sainte Musse', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulon', 'state': 'Paca', 'country': 'France', 'facility': 'H.I.A Saint Anne', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Argenteuil', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Victor Dubos', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Osny', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Clinique Ste Marie', 'geoPoint': {'lat': 49.0701, 'lon': 2.06277}}, {'city': 'Paris', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'state': 'Paris Nord', 'country': 'France', 'facility': 'TENON', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pontoise', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Hpt Rene Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'city': 'Clichy', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'BEAUJON', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Le Chesnay', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Levallois-Perret', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Franco Britannique', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'city': 'Maisons-Laffitte', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Des Courses', 'geoPoint': {'lat': 48.95264, 'lon': 2.14521}}, {'city': 'Neuilly/seine', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'HARTMANN'}, {'city': 'Suresnes', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Angers', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Ico Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Le Mans', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Ch Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Le Mans', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Hélène ALBRAND, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospira, now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospira, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}