Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 10:11 AM
Study NCT ID:
NCT05364905
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-04', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical, biological and treatment characteristics', 'timeFrame': 'up to 3 years', 'description': 'Description of the data'}], 'secondaryOutcomes': [{'measure': 'Progession Free Survival real world (rwPFS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'From the date of initiation of the treatment in the corresponding line to the date of progression or death'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'From the date of initiation of the treatment in the corresponding line to the date of death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology', 'Endometrial Cancer', 'Advanced Cancer', 'Recurrent Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population musy respect all the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult women ≥ 18 years at index date.\n2. Documented diagnosis of advanced recurrent or metastatic endometrial cancer not eligible to primary complete surgery. Patients with interval surgery after primary CT may be eligible.\n3. Index date should represent at least the first\\* or second line\\*\\* chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December 2019.\n4. do not express refusal to her personal data processing or did not express her refusal for deceased patients.\n\nExclusion Criteria:\n\n1. No clinical records for tumor imaging or administration of anti-cancer therapy.\n2. Patients with active malignancy other than EC cancer which contribute significantly to the clinical impairment of the patient during the study period, according to investigator opinion.\n3. Patients lost to follow-up, defined as patients whose last follow-up information occurs less than two years after index date (unless the patient is deceased).\n4. Patient did not receive chemotherapy systemic treatment.\n5. Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.'}, 'identificationModule': {'nctId': 'NCT05364905', 'acronym': 'ENDOVIE', 'briefTitle': 'Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'ARCAGY/ GINECO GROUP'}, 'officialTitle': 'Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study', 'orgStudyIdInfo': {'id': 'GINECO-EN106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients in first line treatment (first chemotherapy for advanced, recurrent or metastatic endometrial cancer) in 2019', 'interventionNames': ['Drug: Chemotherapy']}, {'label': 'Cohort 2', 'description': 'Patients in second line treatment (after one prior systemic chemotherapy) in 2019', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Patients with confirmed advanced, recurrent or metastatic endometrial cancer, treated by chemotherapy in real life-setting, between 1st January 2019 to 31rd December March 2019, in first or second line of chemotherapy.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84918', 'city': 'Avignon', 'country': 'France', 'facility': 'Sainte-Catherine Institut du Cancer Avignon-Provence', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU Besançon - Hôpital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Guillaume BABIN', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Hôpital Morvan CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '37175', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': "Centre d'Oncologie et de Radiothérapie 37", 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '21079', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38028', 'city': 'Grenoble', 'country': 'France', 'facility': 'Groupe Hospitalier Mutualiste de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69737', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'ICL - Centre Alexis Vautrin', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'facility': "ORACLE - Centre d'Oncologie de Gentilly", 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44277', 'city': 'Nantes', 'country': 'France', 'facility': 'Hôpital Privé du Confluent', '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': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Centre ONCOGARD - Institut de cancérologie du Gard', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'facility': 'CHR Orléans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Diaconesses - Croix Saint-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '22190', 'city': 'Plérin', 'country': 'France', 'facility': 'Centre CARIO - HPCA', 'geoPoint': {'lat': 48.53451, 'lon': -2.76975}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers - Hôpital de la Milétrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'ICO - Centre René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'ICANS - Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARCAGY/ GINECO GROUP', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}