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临床试验/NCT04623658
NCT04623658已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Presence of postnatal sequelae

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

结局指标

主要结局

Presence of postnatal sequelae

时间窗: Up to 10 years

Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae

Occurrence of benign or malignant recurrence

时间窗: Up to 10 years

Relapse requiring subsequent surgical procedures and/or chemotherapy

Fetal or neonatal death

时间窗: Before 28 days of life

Intrauterine fetal death, termination of pregnancy or neonatal death

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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