Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04623658

Acronym

PROSTEO

Enrollment

Registered

2020-11-10

Start date

2020-11-30

Completion date

2021-04-30

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacrococcygeal Teratoma

Keywords

Sacrococcygeal teratoma, Prenatal diagnosis, Prenatal counseling, Prognostic factors, Neonatal tumor

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 10 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSabine Sarnacki, MD, PhD

Assistance Publique - Hôpitaux de Paris

STUDY_DIRECTORNicolas Vinit, Resident, MSc