Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-31 @ 3:17 AM
Study NCT ID:
NCT05129969
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Platform Ovarian and Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1975}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Course of treatment (treatment reality).', 'timeFrame': '3 years per patient', 'description': 'Documentation of anamnestic data and therapy sequences.'}], 'secondaryOutcomes': [{'measure': 'Best Response.', 'timeFrame': '3 years per patient', 'description': 'Documentation of response rates per line of treatment.'}, {'measure': 'Progression-free survival.', 'timeFrame': '3 years per patient', 'description': 'Documentation of progression-free survival per line of treatment.'}, {'measure': 'Overall survival.', 'timeFrame': '3 years per patient', 'description': 'Documentation of overall survival per line of treatment.'}, {'measure': 'Health-related quality of life (Patient-reported outcome, PRO).', 'timeFrame': '3 years per patient', 'description': 'Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale'}, {'measure': 'Health-related quality of life (Patient-reported outcome, PRO).', 'timeFrame': '3 years per patient', 'description': 'Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Registry', 'Health service research', 'Epidemiology', 'Germany', 'Palliative treatment', 'Palliative care'], 'conditions': ['Ovarian Cancer', 'Endometrial Cancer', 'Ovary Neoplasm', 'Endometrial Neoplasms', 'Carcinoma, Ovarian', 'Carcinoma', 'Neoplasm, Ovarian']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.', 'detailedDescription': 'SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.\n\nThe registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.\n\nHealth-related quality of life (HRQoL) will be evaluated for up to three years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.', 'genderDescription': 'Ovarian or endometrial cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):\n\n * patients with FIGO stage IIb-IV OC who are starting systemic treatment or\n * patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease.\n* Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.\n* Signed and dated informed consent (IC):\n\n * Patients participating in PRO module: IC before first therapy cycle\n * Patients not participating in PRO module: IC no later than six weeks after start of first therapy cycle\n\nExclusion Criteria:\n\n* newly diagnosed early-stage OC (FIGO stage I-IIa)\n* Low grade mOC OR\n* Early-stage EC (FIGO stage I-II)'}, 'identificationModule': {'nctId': 'NCT05129969', 'acronym': 'SMARAGD', 'briefTitle': 'Registry Platform Ovarian and Endometrial Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': 'SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes', 'orgStudyIdInfo': {'id': 'IOM-110401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ovarian cancer', 'description': 'Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):\n\n* with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or\n* with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease.', 'interventionNames': ["Other: Physician's choice according to patient's needs."]}, {'label': 'Endometrial cancer', 'description': 'Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.', 'interventionNames': ["Other: Physician's choice according to patient's needs."]}], 'interventions': [{'name': "Physician's choice according to patient's needs.", 'type': 'OTHER', 'description': 'Routine care as per site standard.', 'armGroupLabels': ['Endometrial cancer', 'Ovarian cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'iOMEDICO AG', 'role': 'CONTACT', 'email': 'info@iomedico.com', 'phone': '+49 761 152420'}], 'facility': 'Multiple sites all over Germany'}], 'centralContacts': [{'name': 'iOMEDICO AG', 'role': 'CONTACT', 'email': 'info@iomedico.com', 'phone': '+49 761 15242-0'}], 'overallOfficials': [{'name': 'Thomas Decker, Prof.Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ravensburg'}, {'name': 'Ingolf Juhasz-Böss, Prof.Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Freiburg'}, {'name': 'Elmar Stickeler, Prof.Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Aachen'}, {'name': 'Dirk Watermann, Prof.Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Freiburg'}, {'name': 'Anja Welt, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Essen'}, {'name': 'Achim Wöckel, Prof.Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Würzburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}