Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-01 @ 7:42 AM
Study NCT ID:
NCT01008735
Status:
UNKNOWN
Last Update Posted:
2009-11-13
First Post:
2009-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gonadal Toxicity in Women With Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-11', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.', 'timeFrame': 'from end of treatment until date of last contact/visit'}], 'secondaryOutcomes': [{'measure': 'role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage', 'timeFrame': 'from end of treatment until date of last contact/visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with Hodgkin lymphoma diagnosed until 2007 in Italy will be considered eligible for this study. Cases will be identified from the archives of GISL.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients in complete remission after chemotherapy for Hodgkin lymphoma\n* Age ≥ 18 e \\< 40 years\n* Previous regular menstrual cycle\n* No previous or concomitant gynecological diseases affecting reproducing function\n* No other chemo-radiotherapy for other neoplasm\n* Written informed consent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01008735', 'acronym': 'FertHD', 'briefTitle': 'Gonadal Toxicity in Women With Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Studio Linfomi'}, 'officialTitle': 'Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'FertHD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women with hodgkin lymphoma treated with chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Montanini, BSc, PhD', 'role': 'CONTACT', 'email': 'amontanini@unimore.it', 'phone': '+39 059 4223284'}, {'name': 'Massimo Federico, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gruppo Italiano Studio Linfomi', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'centralContacts': [{'name': 'Antonella Montanini, BSc, PhD', 'role': 'CONTACT', 'email': 'amontanini@unimore.it\\', 'phone': '+39 059 4223284'}], 'overallOfficials': [{'name': 'Francesco Angrilli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}, {'name': 'Simona Falorio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}, {'name': 'Massimo Federico, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Studio Linfomi', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Massimo Federico', 'oldOrganization': 'Gruppo Italiano Studio Linfomi'}}}}