Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-30 @ 9:11 PM
Study NCT ID:
NCT05733793
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of different gene alterations found with NGS tests', 'timeFrame': '4years', 'description': 'This percentage will be calculated within enrolled patients that have a report of NGS test at baseline'}], 'secondaryOutcomes': [{'measure': 'Progression-free-survival (PFS)', 'timeFrame': 'until progression disease (up to 4 years)', 'description': 'PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to progression or death for any cause,whichever comes first'}, {'measure': 'Overall survival (OS)', 'timeFrame': '4 years', 'description': 'Overall survival (OS) will be defined as the time between first line therapy start and death from any cause'}, {'measure': 'ORR', 'timeFrame': '4 years', 'description': 'Overall Response Rate (ORR) will be defined as the proportion of patients achieving a complete or partial response to a given therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Next Genaration Sequencing (NGS)', 'Molecular profile'], 'conditions': ['Gynecologic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://usc.istitutotumori.na.it', 'label': 'Description: Sponsor web-site for study conduction'}]}, 'descriptionModule': {'briefSummary': 'Gynger is a no profit, observational study, composed of a retrospective cohort (A) and a prospective cohort (B). The primary aim of this trial is to describe gene profile of Italian gynecological cancers patients, through the centralization of NGS reports performed in clinical practice or collected in clinical trials, and to correlation them with clinical and pathologic features.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with a gynecological cancer with an available NGS report.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form;\n2. Female sex;\n3. Age ≥18 years;\n4. Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);\n5. Availability of NGS report performed on solid tumor tissue from primary or recurrent disease or liquid biopsy; data from NGS assays both in-house (academic test) and commercials can be used regardless of the number of genes analyzed\n\nExclusion Criteria:\n\n* Patients for which the NGS analysis has been performed of germline tissue'}, 'identificationModule': {'nctId': 'NCT05733793', 'acronym': 'GYNGER', 'briefTitle': 'Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients.', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'A Retrospective-prospective, Multicenter, Observational Study Aimed to Record Molecular Data and to Explore Their Correlations With Clinical Outcomes in Gynecological Cancer Patients. The MITO GYNecological Cancers GEnetic Profile Registry (GYNGER) Study.', 'orgStudyIdInfo': {'id': 'Gynger'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A (Retrospective):', 'description': 'Cohort A (Retrospective):\n\n• All consecutive patients diagnosed with gynecological malignancies who have performed an NGS analysis on tumor sample as for clinical practice or as part of a clinical study from the January 1st 2015 until the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients) will be enrolled.', 'interventionNames': ['Other: NGS tests']}, {'label': 'Cohort B (Prospective):', 'description': '• All consecutive patients diagnosed with a gynecological malignancy who perform an NGS analysis on tumor sample as for clinical practice or as part of a clinical practice from the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients) until 1st January 2025.', 'interventionNames': ['Other: NGS tests']}], 'interventions': [{'name': 'NGS tests', 'type': 'OTHER', 'description': 'This study is an observational, the patients with have an available NGS report performed in context of clinical practice or collected in clinical trials.\n\nPatients enrolled in the current study will be managed as for clinical practice and no additional genetic tests or other procedure will be required.', 'armGroupLabels': ['Cohort A (Retrospective):', 'Cohort B (Prospective):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sandro Pignata, MD, PhD', 'role': 'CONTACT', 'email': 's.pignata@istitutotumori.na.it', 'phone': '003908117770755'}, {'name': 'Clorinda Schettino, MD', 'role': 'CONTACT', 'email': 'c.schettino@istitutotumori.na.it', 'phone': '003908117770287'}, {'name': 'Sandro Pignata, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Clorinda Schettino, MD', 'role': 'CONTACT', 'email': 'c.schettino@istitutotumori.na.it', 'phone': '003908117770287'}, {'name': 'Sandro Pignata, MD', 'role': 'CONTACT', 'email': 's.pignata@istitutotumori.na.it', 'phone': '003908117770355'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}