跳至主要内容
临床试验/NCT06365268
NCT06365268已完成不适用

Perinatal Thoraco-abdominal Tumors Management in Infants : a Multicenter Experience

Assistance Publique - Hôpitaux de Paris5 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年9月5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
152
试验地点
5
主要终点
Description of the developmental spectrum of solid congenital truncal tumors

研究概览

简要总结

Congenital tumors are a rare diagnosis in the fetus and newborn. They differ from those of children and adults in terms of the nature, location and evolution of the tumor.

Indeed, some histologically benign tumors may have lethal potential in utero (e.g. sacrococcygeal teratomas) or even undergo malignant transformation if left untreated. In contrast, other tumors that are malignant by histological criteria may have a very good prognosis, regressing spontaneously within the first year of life (e.g. neuroblastoma).

Despite advances in imaging, benign and malignant solid tumors remain a major diagnostic and prognostic challenge in the antenatal context.

The management of congenital tumors requires multidisciplinary expertise, taking into account the perinatal context, which poses specific problems, particularly in terms of therapeutic aspects, but also the frequent existence of associated malformations and/or genetic predisposition syndromes.

This study focuses on solid tumors of the thoraco-abdomino-pelvic region, the main objective being to investigate the correlation between antenatal clinical and radiological analysis and confirmed postnatal diagnosis of congenital solid truncal tumors, as well as the developmental spectrum in which they fit.

详细描述

Congenital tumors are a rare diagnosis in the fetus and newborn. Despite advances in imaging techniques, it remains a major diagnostic and prognostic challenge. The congenital tumor differs from that of the child and adult in terms of tumoral nature, localization and evolution.

The investigation of a congenital tumor must be multidisciplinary and exhaustive, since it is estimated that congenital tumors are associated with a genetic predisposition syndrome in 10% to 15% of cases, and this proportion is set to rise in the coming years.

Precise analysis of the spectrum of tumors involved, and diagnosis of the nature of the tumor, are the basis for advice and pre- and post-natal care. Prenatal information given to parents must be accurate and precise, as the diagnosis of a congenital tumor may lead to a request for medical termination of pregnancy.

Diagnostic performance in the characterization of a tumor mass in antenatal care is still imperfect.

Diagnostic performance in the characterization of a tumor mass in antenatal care is still imperfect.

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 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Information of the holders of parental authority of the patients concerned by the research
  • Malignant or benign solid tumor
  • Thoracic, abdominal or pelvic location
  • Clinico-radiological or histological diagnosis confirmed postnatally up to 1 year of life with onset of symptoms in the first three months of life
  • Mother-child whose care course for the child's congenital axial tumor included treatment at the AP-HP

排除标准

  • Opposition from holders of parental authority of patients
  • Sacrococcygeal teratomas
  • Central nervous system tumors
  • Heart tumors
  • Ovarian cysts
  • Head and neck tumors
  • Congenital leukemia and hemopathy

结局指标

主要结局

Description of the developmental spectrum of solid congenital truncal tumors

时间窗: 3 years

Study of data from the patient's medical file.

Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors

时间窗: 3 years

Study of data from the patient's medical file.

次要结局

  • Characteristics and location of the tumor on pre- and post-natal imaging(3 years)
  • Ile-de-France epidemiology of perinatal tumors(Through study completion, an average of 4 months)
  • Evolution of solid congenital truncal tumors(Through study completion, an average of 4 months)
  • Associated genetic abnormalities and malformations(Through study completion, an average of 4 months)
  • Intercurrent obstetric events and obstetric outcomes based on the diagnoses made(Through study completion, an average of 4 months)
  • Development of a management algorithm based on prenatal findings(Through study completion, an average of 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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