Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma — PROSTEO  

Sacrococcygeal Teratoma Clinical Trial

Official title: Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma: a Multicenter Retrospective Study With Review of the Literature

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Sacrococcygeal teratoma (SCT) is the most common fetal and neonatal tumor. Although mostly benign, SCT can lead to perinatal mortality and long-term sequelae. 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. ;

Related Conditions & MeSH terms

• Sacrococcygeal Teratoma
• Teratoma

• NCT number: NCT04623658
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Start date: November 30, 2020
• Completion date: April 30, 2021