Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04623658 |
Other study ID # |
APHP200355 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 30, 2020 |
Est. completion date |
April 30, 2021 |
Study information
Verified date |
September 2021 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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.