Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma (PROSTEO)

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

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.

Study Overview

• Status: Completed
• Conditions: Sacrococcygeal Teratoma

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker-Enfants Malades Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fetuses and infants diagnosed with sacrococcygeal teratoma and cared for between 2007 and 2017 in the main Parisian fetal medicine and pediatric surgery units: Necker-Enfants Malades Hospital, Antoine Béclère Hospital, Armand Trousseau Hospital, Robert Debré Hospital and Le Kremlin-Bicêtre Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Sacrococcygeal teratoma; Fetuses and infants diagnosed with sacrococcygeal teratoma and cared for between 2007 and 2017 in the main Parisian fetal medicine and pediatric surgery units: Necker-Enfants Malades Hospital, Antoine Béclère Hospital, Armand Trousseau Hospital, Robert Debré Hospital and Le Kremlin-Bicêtre Hospital.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Sabine Sarnacki, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Nicolas Vinit, Resident, MSc, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Sacrococcygeal teratoma; Prognostic factors; Prenatal diagnosis; Prenatal counseling; Neonatal tumor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma
• Other Study ID Numbers: APHP200355

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No