Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04526392
Status:
UNKNOWN
Last Update Posted:
2020-08-25
First Post:
2020-07-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536396', 'term': 'Neonatal ovarian cyst'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age of onset of first menstruation', 'timeFrame': 'Day 1', 'description': 'Age of onset of first menstruation defined with one decimal place (year and month).'}], 'secondaryOutcomes': [{'measure': 'Average age of maternal and sister rules', 'timeFrame': 'Day 1', 'description': 'Average age of maternal and sister menstruation.'}, {'measure': 'Ovarian volumes', 'timeFrame': 'Day 1', 'description': 'Homo and contralateral ovarian volumes at the cyst.'}, {'measure': 'Presence or not of follicles', 'timeFrame': 'Day 1', 'description': 'Presence or not of follicles on both ovaries.'}, {'measure': 'first menstruation description - age of breast onset', 'timeFrame': 'Day 1', 'description': 'Age of breast onset'}, {'measure': 'first menstruation description - cycle length', 'timeFrame': 'Day 1', 'description': 'cycle length in the last three months'}, {'measure': 'first menstruation description - cycle disorder', 'timeFrame': 'Day 1', 'description': 'rate of patients with cycle disorder'}, {'measure': 'first menstruation description dysmenorrhoea.', 'timeFrame': 'Day 1', 'description': 'dysmenorrhoea.'}, {'measure': 'first menstruation description menorrhagia', 'timeFrame': 'Day 1', 'description': 'menorrhagia'}, {'measure': 'percentage of hyperandrogenism', 'timeFrame': 'Day 1', 'description': 'Percentage of girls with clinical signs of hyperandrogenism or elevated testosterone levels.'}, {'measure': 'Hormonal levels - AMH', 'timeFrame': 'Day 1', 'description': 'AMH levels'}, {'measure': 'Hormonal levels - LH', 'timeFrame': 'Day 1', 'description': 'Luteinizing hormone (LH) levels'}, {'measure': 'Hormonal levels - FSH', 'timeFrame': 'Day 1', 'description': 'follicle stimulating hormone (FSH) levels'}, {'measure': 'Hormonal levels - estradiol', 'timeFrame': 'Day 1', 'description': 'estradiol levels'}, {'measure': 'rate of ovarian cyst recurrence', 'timeFrame': 'Day 1', 'description': 'Ovarian cyst recurrence rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child', 'puberty'], 'conditions': ['Fetal Ovarian Cyst']}, 'descriptionModule': {'briefSummary': 'This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.', 'detailedDescription': 'These cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. Apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life.\n\nSurveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. In the case of complicated cysts, oophorectomy was necessary in 9 cases. In the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p\\<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. The origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. No series in the literature gives the long-term ovarian prognosis for these patients. We wish to evaluate the pubertal evolutionary profile of patients followed at the University Hospital for KOF. The data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in France.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Young girls who have to answer a questionnaire on their pubertal development. Estimated duration of data collection by questionnaire for one participant: 30 minutes maximum.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 8 years of age at the time of inclusion.\n* Patients being followed for fetal ovarian cyst.\n* Minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition.\n* Patients covered by a social security scheme.\n\nExclusion Criteria:\n\n* Patients less than 8 years of age at the time of inclusion\n* Ovarian cysts outside the neonatal period\n* Refusal to participate.\n* Opposition to disclosure of neonatal data.\n* Pregnant or nursing patient.'}, 'identificationModule': {'nctId': 'NCT04526392', 'acronym': 'KOF', 'briefTitle': 'Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst', 'orgStudyIdInfo': {'id': 'RC31/19/0497'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire', 'description': 'Patients will choose how they wish to complete the Pubertal Course Questionnaire: electronically (web link), on paper, by telephone, or face-to-face at a follow-up consultation.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Pubertal course questionnaire', 'armGroupLabels': ['Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine PIENKOWSKI, MD', 'role': 'CONTACT', 'email': 'pienkowski.c@chu-toulouse.fr', 'phone': '5 34 55 85 53', 'phoneExt': '+33'}, {'name': 'Catherine PIENKOWSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Catherine PIENKOWSKI, MD', 'role': 'CONTACT', 'email': 'pienkowski.c@chu-toulouse.fr', 'phone': '5 34 55 85 53', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Catherine PIENKOWSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}