Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

Sacrococcygeal Teratoma Clinical Trial

— PROSTEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623658
• Other study ID #: APHP200355
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Sacrococcygeal Teratoma
• Teratoma

Locations

Country	Name	City	State
France	Necker-Enfants Malades Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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