Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623658
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2020-10-28
Brief Title:
Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma a Multicenter Retrospective Study With Review of the Literature
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSTEO
Brief 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
Detailed 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 andor 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 parents 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
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 andor 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 parents 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None