NCT04623658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

October 28, 2020

Last Update Submit

March 6, 2026

Conditions

Sacrococcygeal Teratoma

Keywords

Sacrococcygeal teratomaPrenatal diagnosisPrenatal counselingPrognostic factorsNeonatal tumor

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Fetuses and infants (\< 1 year) diagnosed with benign sacrococcygeal teratoma
  • Cared for between January 2007 and December 2017 in the participating centers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker-Enfants Malades Hospital

Paris, 75015, France

Location

Related Publications (2)

  • 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.

    PMID: 40972984RESULT

  • 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.

    PMID: 39482803RESULT

Study Officials

  • Sabine Sarnacki, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Nicolas Vinit, Resident, MSc

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 10, 2020

Study Start

November 30, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

FR(1)