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CompletedNCT04623658PROSTEOUpdated Mar 9, 2026

Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

An observational study in Sacrococcygeal Teratoma, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
84
Ages
Up to 10 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Sacrococcygeal Teratoma

Keywords

  • Sacrococcygeal teratoma
  • Prenatal diagnosis
  • Prenatal counseling
  • Prognostic factors
  • Neonatal tumor
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
84 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Presence of postnatal sequelae

    Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae

    Time frame: Up to 10 years

  2. Fetal or neonatal death

    Intrauterine fetal death, termination of pregnancy or neonatal death

    Time frame: Before 28 days of life

  3. Occurrence of benign or malignant recurrence

    Relapse requiring subsequent surgical procedures and/or chemotherapy

    Time frame: Up to 10 years

07

Study locations

1 site
  • Necker-Enfants Malades Hospital
    Paris, 75015, France
08

References and documents

Publications

  • Vinit N, Bonnard A, Irtan S, Fouquet V, Ville Y, Rosenblatt J, Jouannic JM, Benachi A, Khen-Dunlop N, Lapillonne A, Beaudoin S, Rousseau V, Salomon LJ, Sarnacki S. Perinatal Prognostic Factors of Recurrence or Functional Sequelae in Neonatal Sacrococcygeal Teratoma, and Implications for Prenatal Counselling: A Multicenter Retrospective Study. J Pediatr Surg. 2025 Dec;60(12):162687. doi: 10.1016/j.jpedsurg.2025.162687. Epub 2025 Sep 17. PubMed 40972984 ↗
  • Vinit N, Benachi A, Rosenblatt J, Jouannic JM, Rousseau V, Bonnard A, Irtan S, Fouquet V, Ville Y, Khen-Dunlop N, Lapillonne A, Jais JP, Beaudoin S, Salomon LJ, Sarnacki S. Growth velocity of fetal sacrococcygeal teratoma as predictor of perinatal morbidity and mortality: multicenter study. Ultrasound Obstet Gynecol. 2024 Nov;64(5):651-660. doi: 10.1002/uog.29110. PubMed 39482803 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04623658
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Nov 10, 2020
Start date
Nov 30, 2020
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Mar 9, 2026

Study contacts

Sabine Sarnacki, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris
Nicolas Vinit, Resident, MSc
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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