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Spots Global Cancer Trial Database for Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

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Trial Identification

Brief Title: 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 ID: NCT04623658

Interventions

Study Description

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

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

Necker-Enfants Malades Hospital, Paris, , France

Contact Details

Name: Sabine Sarnacki, MD, PhD

Affiliation: Assistance Publique - Hôpitaux de Paris

Role: PRINCIPAL_INVESTIGATOR

Name: Nicolas Vinit, Resident, MSc

Affiliation: Assistance Publique - Hôpitaux de Paris

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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