Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-06 @ 6:54 AM
Study NCT ID:
NCT01503034
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2011-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2011-12-30', 'studyFirstSubmitQcDate': '2011-12-30', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.'}], 'secondaryOutcomes': [{'measure': 'the support of breast cancer cases occured during pregnancy', 'timeFrame': '5 years', 'description': "Description of the anti-tumor treatment (surgery, radiotherapy, chemotherapy, hormone therapy, targeted therapy), of the imaging performed and of the childbirth (programmed or not, vaginal or caesarean section, baby's condition at birth, etc.)."}, {'measure': 'Tumor characteristics', 'timeFrame': '5 years', 'description': 'Description of the tumor characteristics on the diagnostic biopsy or on the surgical specimen : histological type, Her2 status, hormone receptor status, etc.'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'The disease-free survival is calculated from the time elapsed between the breast cancer diagnostic date and the first recurrence of the disease.'}, {'measure': 'Case-control comparison', 'timeFrame': '5 years', 'description': 'Comparison of the tumoral characteristics, the patient care and the prognosis of women with breast cancer appeared during a pregnancy, with non-pregnant women of the same age.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnant women'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).', 'detailedDescription': 'Investigators will explain the purpose of the study to the eligible patients, still alive, and will inform them verbally and in writing, using the information note, of their possibility of refusal. No information will be made for deceased patients.\n\nThe investigators will complete the case report forms on paper and then will send them by mail.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study being retrospective, we will include all the subjects that meet our inclusion criteria over the period analyzed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 or over\n* Confirmed histological diagnosis of invasive breast cancer\n* No known metastasis\n* For the cases :\n\n * Patients pregnant at the time of the first diagnosis\n * 1st diagnosis between 2000 and 2014\n* For the controls :\n\n * Patients not pregnant at the time of the first diagnosis\n * 1st diagnosis between 2000 and 2009\n\nExclusion Criteria:\n\n* Patients who have undergone an induced abortion after the diagnosis of breast cancer\n* Patients with a history of breast cancer'}, 'identificationModule': {'nctId': 'NCT01503034', 'briefTitle': 'Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014', 'orgStudyIdInfo': {'id': 'Cancer et grossesse'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'This cohort is made up of pregnant women with a breast cancer diagnosed between 2000 and 2014.'}, {'label': 'Compared cohort', 'description': 'This cohort is made up of non-pregnant women with a breast cancer diagnosed between 2000 and 2009.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '56150', 'city': 'Baud', 'country': 'France', 'facility': 'Cabinet Dr Le Guen Naas', 'geoPoint': {'lat': 47.8759, 'lon': -3.01926}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHR', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '95300', 'city': 'Cergy-Pontoise', 'country': 'France', 'facility': 'Centre Hospitalier René Dubos', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59187', 'city': 'Dechy', 'country': 'France', 'facility': 'Centre Léonard de Vinci', 'geoPoint': {'lat': 50.35, 'lon': 3.11667}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Départemental de Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59045', 'city': 'Lille', 'country': 'France', 'facility': 'Centre de Pharmacovigilance', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '56322', 'city': 'Lorient', 'country': 'France', 'facility': 'Centre Hospitalier de Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CHRU La Peyronie et Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44202', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Catherine de Sienne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon-Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '51056', 'city': 'Reims', 'country': 'France', 'facility': 'Institut Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique de Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '22015', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Clinique Radiologique', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67065', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Régaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '59200', 'city': 'Tourcoing', 'country': 'France', 'facility': 'Cabinet Dr Leroy', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Laurence VANLEMMENS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}