Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 5:16 AM
Study NCT ID:
NCT01183832
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2010-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 490}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-17', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'radiation side effects', 'timeFrame': '5 years after the end of radiotherapy', 'description': 'Describe, in real situation, the ionisant radiation effects on the healthy tissues in patients receiving anastrazole in association or sequential with radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'radiotherapy', 'hormonotherapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are post-menopausal women treated for a breast concer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal woman without superior age limit\n* No metastatic breast cancer, stade I-II, estrogen receptor positive or progesterone receptor positive, treated by conservative surgery or total mastectomy and requiring additive treatment by radiotherapy and hormonotherapy\n* The patients including in another clinical trial can be include in this observatory'}, 'identificationModule': {'nctId': 'NCT01183832', 'acronym': 'ORACLES', 'briefTitle': 'Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects', 'orgStudyIdInfo': {'id': 'ORACLES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Concomitant', 'description': 'In this group, anastrazole is concomitant to the radiotherapy'}, {'label': 'Sequential', 'description': 'In this group, anastrazole is sequential to the radiotherapy (start after the end of radiotherapy)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Aubagne', 'country': 'France', 'facility': 'Clinique La Casamance', 'geoPoint': {'lat': 43.29276, 'lon': 5.57067}}, {'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'Hôpital Duchêne', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Charleville', 'country': 'France', 'geoPoint': {'lat': 48.81286, 'lon': 3.66762}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': "Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Catherine de Sienne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier St Grégoire', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles cliniques nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine LACCASSAGNE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Clinique de la Roseraie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier LYON Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique de Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Centre: Clinique Armoricaine de Radiologie', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulon', 'country': 'France', 'facility': 'Centre de radiothérapie Saint-Louis', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Centre Claudius REGAUD', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Monaco', 'country': 'Monaco', 'facility': 'Centre CHPG', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}], 'overallOfficials': [{'name': 'Yazid BELKACEMI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}