Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02878434
Status:
RECRUITING
Last Update Posted:
2020-11-18
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fertility Preservation in Young Women With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-22', 'size': 603183, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-28T08:11', 'hasProtocol': True}, {'date': '2018-10-02', 'size': 368470, 'label': 'Informed Consent Form: adult', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-03-28T08:16', 'hasProtocol': False}, {'date': '2018-10-02', 'size': 381368, 'label': 'Informed Consent Form: child -18y', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-03-28T08:17', 'hasProtocol': False}, {'date': '2018-10-02', 'size': 381360, 'label': 'Informed Consent Form: parent for child -18y', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-05-22T04:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2032-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertility Outcome', 'timeFrame': '10 years', 'description': 'pregnancy rate'}], 'secondaryOutcomes': [{'measure': 'Oncological Outcome', 'timeFrame': '5 years', 'description': 'Recurrence of cancer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Fertility', 'Pregnancy', 'Chemotherapy', 'Radiotherapy', 'Long term', 'Follow up'], 'conditions': ['Cancer', 'Fertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cancerinpregnancy.org', 'label': 'This site provides background information on the problem of cancer in pregnancy and cancer and fertility'}]}, 'descriptionModule': {'briefSummary': 'The researchers aim to record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.\n\nStudy population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.', 'detailedDescription': 'Cancer is the second leading cause of death during the reproductive years. The long term survival improves for most cancers, reaching 80% for pediatric cancer and more than 70% for cancers in adults between 20 and 49 years of age. Early detection and improvements in cancer treatment contribute to these figures. As a result, quality of life of which preservation of fertility is one aspect, becomes more important. Fertility may however be influenced by surgery and by the gonadotoxic effects of chemo and/or radiotherapy. Therefore, fertility sparing treatments are offered to young patients in order to maintain the wish to conceive after cancer treatment. This however is associated with deviation of standard treatment and many different strategies are applied among different centers. In addition, there is a lack of studies investigating the oncological safety of these fertility sparing treatment protocols. The results of this study will enable us to better inform clinicians and patients on the efficacy of fertility sparing cancer treatment.\n\nObjective:\n\nTo record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.\n\nStudy design: International multicentre prospective observational trial\n\nStudy population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.\n\nMain study parameters/endpoints:\n\nRegistration of cancer diagnosis, treatment and outcome. Both the oncologic and fertility outcome is registered.\n\nAll patients receive fertility sparing cancer treatment on their specific request.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women diagnosed with cancer for whom a fertility preserving cancer treatment is applied will be considered for inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young women who want to preserve their fertility during cancer treatment. Patients need to give their signed and written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent'}, 'identificationModule': {'nctId': 'NCT02878434', 'briefTitle': 'Fertility Preservation in Young Women With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'officialTitle': 'Fertility Preservation in Young Women With Cancer: an International Registration Study From the International Network on Cancer, Infertility and Pregnancy (INCIP)', 'orgStudyIdInfo': {'id': 'INCIP Fer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group'}, {'label': 'control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Katrien Van Tornout', 'role': 'CONTACT', 'email': 'katrien.vantornout@uzleuven.be', 'phone': '+3216342876'}, {'name': 'Frédéric Amant, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Gasthuisberg, Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Christianne Lok, MD, PhD', 'role': 'CONTACT', 'email': 'c.lok@nki.nl'}, {'name': 'Christianne Lok, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Katrien Van Tornout', 'role': 'CONTACT', 'email': 'katrien.vantornout@uzleuven.be', 'phone': '+3216342876'}], 'overallOfficials': [{'name': 'Frédéric Amant, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Gasthuisberg & KU Leuven, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'NKI-AvL', 'class': 'UNKNOWN'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'N.N. Blokchin NMRCO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Frederic Amant', 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}