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Completed

NCT Number: NCT04623658

Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

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.

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Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker-Enfants Malades Hospital

Paris, 75015, France

About this study

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:

  • 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
  • A risk of benign or malignant tumor recurrence
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of postnatal sequelae

    Time frame: Up to 10 years

    Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae

  2. Fetal or neonatal death

    Time frame: Before 28 days of life

    Intrauterine fetal death, termination of pregnancy or neonatal death

  3. Occurrence of benign or malignant recurrence

    Time frame: Up to 10 years

    Relapse requiring subsequent surgical procedures and/or chemotherapy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PROSTEO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2020
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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