Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-08
Brief Title:
Perinatal Thoraco-abdomino-pelvic Tumors Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Perinatal Thoraco-abdominal Tumors Management in Infants a Multicenter Experience
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTRAST
Brief Summary:
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 eg 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 eg 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 andor 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
Indeed some histologically benign tumors may have lethal potential in utero eg 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 eg 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 andor 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
Detailed Description:
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
By reporting on our experience in the management of congenital tumors in the Ile-de-France region we aim to improve our understanding of the developmental spectrum in which these tumors occur By clarifying the diagnosis the resulting management can be optimized and adapted to each situation The challenge is to treat the tumor effectively and sustainably while avoiding overly aggressive treatments when they are not indicated Post-natal therapies will be described in detail for each situation to produce a simplified algorithm for management
The quality of this information will condition the parents experience and avoid requests for medical termination of pregnancy for benign tumors andor spontaneous involution On the contrary this will be discussed in rare cases of very aggressive tumor involving the functional or vital prognosis of the unborn child or occurring in a context of known genetic predisposition
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
By reporting on our experience in the management of congenital tumors in the Ile-de-France region we aim to improve our understanding of the developmental spectrum in which these tumors occur By clarifying the diagnosis the resulting management can be optimized and adapted to each situation The challenge is to treat the tumor effectively and sustainably while avoiding overly aggressive treatments when they are not indicated Post-natal therapies will be described in detail for each situation to produce a simplified algorithm for management
The quality of this information will condition the parents experience and avoid requests for medical termination of pregnancy for benign tumors andor spontaneous involution On the contrary this will be discussed in rare cases of very aggressive tumor involving the functional or vital prognosis of the unborn child or occurring in a context of known genetic predisposition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None