Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT04623658
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of postnatal sequelae', 'timeFrame': 'Up to 10 years', 'description': 'Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae'}, {'measure': 'Fetal or neonatal death', 'timeFrame': 'Before 28 days of life', 'description': 'Intrauterine fetal death, termination of pregnancy or neonatal death'}, {'measure': 'Occurrence of benign or malignant recurrence', 'timeFrame': 'Up to 10 years', 'description': 'Relapse requiring subsequent surgical procedures and/or chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sacrococcygeal teratoma', 'Prenatal diagnosis', 'Prenatal counseling', 'Prognostic factors', 'Neonatal tumor'], 'conditions': ['Sacrococcygeal Teratoma']}, 'referencesModule': {'references': [{'pmid': '40972984', 'type': 'RESULT', 'citation': 'Vinit N, Bonnard A, Irtan S, Fouquet V, Ville Y, Rosenblatt J, Jouannic JM, Benachi A, Khen-Dunlop N, Lapillonne A, Beaudoin S, Rousseau V, Salomon LJ, Sarnacki S. Perinatal Prognostic Factors of Recurrence or Functional Sequelae in Neonatal Sacrococcygeal Teratoma, and Implications for Prenatal Counselling: A Multicenter Retrospective Study. J Pediatr Surg. 2025 Dec;60(12):162687. doi: 10.1016/j.jpedsurg.2025.162687. Epub 2025 Sep 17.'}, {'pmid': '39482803', 'type': 'RESULT', 'citation': 'Vinit N, Benachi A, Rosenblatt J, Jouannic JM, Rousseau V, Bonnard A, Irtan S, Fouquet V, Ville Y, Khen-Dunlop N, Lapillonne A, Jais JP, Beaudoin S, Salomon LJ, Sarnacki S. Growth velocity of fetal sacrococcygeal teratoma as predictor of perinatal morbidity and mortality: multicenter study. Ultrasound Obstet Gynecol. 2024 Nov;64(5):651-660. doi: 10.1002/uog.29110.'}]}, 'descriptionModule': {'briefSummary': 'Sacrococcygeal teratoma (SCT) is the most common fetal and neonatal tumor. However, predicting factors of evolution, sequelae and relapse are still unreliable because of small-cohort studies. This study aims at identifying prenatal and postnatal prognostic factors of evolution of SCT during pregnancy, of postnatal relapse, and of medium and long-term sequelae (urinary, digestive, esthetic, psychologic) in order to improve parental counseling when the diagnosis of SCT is made during pregnancy.', 'detailedDescription': "Sacrococcygeal teratoma (SCT) is the most common fetal and neonatal tumor. Although mostly benign, SCT can lead to perinatal mortality and long-term sequelae.\n\nThree main risks occur throughout the evolution of SCT:\n\n1. A perinatal life-threatening risk related to the importance of vascularization since SCT can lead to a true arteriovenous fistula with the risk of cardiac failure\n2. A risk of benign or malignant tumor recurrence\n3. A risk of medium and long-term sequelae, mostly urinary and/or digestive disorders but also aesthetic and psychologic.\n\nIn most cases, a prenatal diagnosis is made for which physicians are expected to give a prognosis and counsel parents about medium and long-term complications. However, there is no robust data to date correlating prenatal and postnatal features to prenatal and postnatal evolution of the tumor. The situation is all the more delicate as the information given by the physician can lead to the parent's will to terminate the pregnancy. This retrospective multicentric study aims at identifying prenatal and postnatal prognostic factors of SCT evolution during pregnancy, the occurrence of postnatal relapse after surgical excision, and medium- and long-term sequelae. The primary goal of this study is to improve prenatal parental counseling when the diagnosis of SCT is made."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fetuses and infants diagnosed with sacrococcygeal teratoma and cared for between 2007 and 2017 in the main Parisian fetal medicine and pediatric surgery units: Necker-Enfants Malades Hospital, Antoine Béclère Hospital, Armand Trousseau Hospital, Robert Debré Hospital and Le Kremlin-Bicêtre Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fetuses and infants (\\< 1 year) diagnosed with benign sacrococcygeal teratoma\n* Cared for between January 2007 and December 2017 in the participating centers\n\nExclusion Criteria:\n\n* Currarino syndrome\n* Other benign sacrococcygeal teratoma discovered after 1 year old or malignant sacrococcygeal tumors'}, 'identificationModule': {'nctId': 'NCT04623658', 'acronym': 'PROSTEO', 'briefTitle': 'Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma: a Multicenter Retrospective Study With Review of the Literature', 'orgStudyIdInfo': {'id': 'APHP200355'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sacrococcygeal teratoma', 'description': 'Fetuses and infants diagnosed with sacrococcygeal teratoma and cared for between 2007 and 2017 in the main Parisian fetal medicine and pediatric surgery units: Necker-Enfants Malades Hospital, Antoine Béclère Hospital, Armand Trousseau Hospital, Robert Debré Hospital and Le Kremlin-Bicêtre Hospital.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker-Enfants Malades Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Sabine Sarnacki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Nicolas Vinit, Resident, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}