Clinical trial NCT04623658: Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma
Official title: Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma: a Multicenter Retrospective Study With Review of the Literature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacrococcygeal Teratoma
Keywords: Sacrococcygeal teratoma
Prenatal diagnosis
Prenatal counseling
Prognostic factors
Neonatal tumor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 84
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of postnatal sequelae
timeFrame: Up to 10 years
measure: Fetal or neonatal death
timeFrame: Before 28 days of life
measure: Occurrence of benign or malignant recurrence
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker-Enfants Malades Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sabine Sarnacki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas Vinit, Resident, MSc
role: STUDY_DIRECTOR
References: