Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma
NCT ID: NCT04623658
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
84 participants
OBSERVATIONAL
2020-11-30
2021-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
NCT06720844
A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip
NCT04972370
Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
NCT04186130
Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia
NCT04422067
In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
NCT06796972
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Three main risks occur throughout the evolution of SCT:
1. 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
2. A risk of benign or malignant tumor recurrence
3. A risk of medium and long-term sequelae, mostly urinary and/or digestive disorders but also aesthetic and psychologic.
In 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sacrococcygeal teratoma
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cared for between January 2007 and December 2017 in the participating centers
Exclusion Criteria
* Other benign sacrococcygeal teratoma discovered after 1 year old or malignant sacrococcygeal tumors
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sabine Sarnacki, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Nicolas Vinit, Resident, MSc
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Necker-Enfants Malades Hospital
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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 Sep 17;60(12):162687. doi: 10.1016/j.jpedsurg.2025.162687. Online ahead of print.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP200355
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.