Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

Completed

• Conditions: Sacrococcygeal Teratoma

• Registration Number: NCT04623658
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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.

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Study Start: 2020-11-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Fetuses and infants (< 1 year) diagnosed with benign sacrococcygeal teratoma
• Cared for between January 2007 and December 2017 in the participating centers

Exclusion Criteria

• Currarino syndrome
• Other benign sacrococcygeal teratoma discovered after 1 year old or malignant sacrococcygeal tumors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of postnatal sequelae	Up to 10 years	Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae
Occurrence of benign or malignant recurrence	Up to 10 years	Relapse requiring subsequent surgical procedures and/or chemotherapy
Fetal or neonatal death	Before 28 days of life	Intrauterine fetal death, termination of pregnancy or neonatal death

Trial Locations

Locations (1)

Necker-Enfants Malades Hospital; 🇫🇷 Paris, France