Perinatal Thoraco-abdomino-pelvic Tumors Study (CONTRAST)

September 15, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 and/or 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 Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92140
        • Hôpital Antoine Béclère
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Paris, France, 75019
        • Hopital Robert Debre
      • Paris, France, 75012
        • Hôpital Armand Trousseau
      • Paris, France, 75015
        • Hôpital Necker-Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Mother-child whose care course for the child's congenital axial tumor included treatment at the AP-HP (Assistance Publique - Hôpitaux de Paris) between 2010 and 2021. Fetus presenting a malignant or benign solid tumor of thoracic, abdominal or pelvic location and whose clinico-radiological or histological diagnosis is confirmed postnatally up to 1 year of life with the onset of symptoms in the first three months of life.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Mother-child whose care course for the child's congenital axial tumor included treatment at the AP-HP between 2010 and 2021. Fetus presenting a malignant or benign solid tumor of thoracic, abdominal or pelvic location and whose clinico-radiological or histological diagnosis is confirmed postnatally up to 1 year of life with the onset of symptoms in the first three months of life.
Other: Collection of data from the patient's medical file
Collection of data from the patient's medical file. The data collected concerns a period of three years maximum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors
Time Frame: 3 years
Study of data from the patient's medical file.
3 years
Description of the developmental spectrum of solid congenital truncal tumors
Time Frame: 3 years
Study of data from the patient's medical file.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics and location of the tumor on pre- and post-natal imaging
Time Frame: 3 years
Description of the characteristics and location of the tumor on pre- and post-natal imaging: ultrasound, MRI, CT scan.
3 years
Ile-de-France epidemiology of perinatal tumors
Time Frame: Through study completion, an average of 4 months
Description of the epidemiology of perinatal tumors in the Paris region.
Through study completion, an average of 4 months
Evolution of solid congenital truncal tumors
Time Frame: Through study completion, an average of 4 months
Description of the evolution of solid congenital truncal tumors.
Through study completion, an average of 4 months
Associated genetic abnormalities and malformations
Time Frame: Through study completion, an average of 4 months
Description of genetic abnormalities and malformations that have been identified and associated with the tumor.
Through study completion, an average of 4 months
Intercurrent obstetric events and obstetric outcomes based on the diagnoses made
Time Frame: Through study completion, an average of 4 months
Description of intercurrent obstetric events as well as the obstetric outcome based on the diagnoses made.
Through study completion, an average of 4 months
Development of a management algorithm based on prenatal findings
Time Frame: Through study completion, an average of 4 months
Propose a management algorithm based on prenatal findings developed from the study data.
Through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Sabine SARNACKI, M.D., PhD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Chelsea KHAWAND, M.D., Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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