Perinatal Solid Tumors of the Thoraco-abdomino-pelvic RegionCONTRASTNCT06365268
Perinatal Thoraco-abdomino-pelvic Tumors Study
An observational study of Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial 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 (e.g. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region
- What is being tested?
- Collection of data from the patient's medical file
- How many people
- 152 participants
- Where
- 5 sitesFrance
- Study dates
- 5 Sep 2024to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Antoine Béclère
Clamart, 92140
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Armand Trousseau
Paris, 75012
Hôpital Necker-Enfants Malades
Paris, 75015
Hôpital Robert Debré
Paris, 75019
About this study
Official title: 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).
Read more
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.
Read the 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.
- Being tested
- Collection of data from the patient's medical file
- Keywords
- Congenital truncal tumors, Antenatal diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from the patient's medical fileOther
Collection of data from the patient's medical file. The data collected concerns a period of three years maximum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors
Study of data from the patient's medical file.
Measured: 3 years
Description of the developmental spectrum of solid congenital truncal tumors
Study of data from the patient's medical file.
Measured: 3 years
Secondary outcomes (6)
Characteristics and location of the tumor on pre- and post-natal imaging
Description of the characteristics and location of the tumor on pre- and post-natal imaging: ultrasound, MRI, CT scan.
Measured: 3 years
Ile-de-France epidemiology of perinatal tumors
Description of the epidemiology of perinatal tumors in the Paris region.
Measured: Through study completion, an average of 4 months
Evolution of solid congenital truncal tumors
Description of the evolution of solid congenital truncal tumors.
Measured: Through study completion, an average of 4 months
Associated genetic abnormalities and malformations
Description of genetic abnormalities and malformations that have been identified and associated with the tumor.
Measured: Through study completion, an average of 4 months
Intercurrent obstetric events and obstetric outcomes based on the diagnoses made
Description of intercurrent obstetric events as well as the obstetric outcome based on the diagnoses made.
Measured: Through study completion, an average of 4 months
Development of a management algorithm based on prenatal findings
Propose a management algorithm based on prenatal findings developed from the study data.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start5 Sep 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Perinatal Solid Tumors of the Thoraco-abdomino-pelvic RegionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabine SARNACKI, M.D., PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisChelsea KHAWAND, M.D., Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365268
- Sponsor's protocol ID
- APHP231139
- Acronym
- CONTRAST
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Isaacs H Jr. Perinatal (congenital and neonatal) neoplasms: a report of 110 cases. Pediatr Pathol. 1985;3(2-4):165-216. doi: 10.3109/15513818509078782.
PubMed 3879355Moore SW, Satge D, Sasco AJ, Zimmermann A, Plaschkes J. The epidemiology of neonatal tumours. Report of an international working group. Pediatr Surg Int. 2003 Sep;19(7):509-19. doi: 10.1007/s00383-003-1048-8. Epub 2003 Sep 11.
PubMed 14523568Geurten C, Geurten M, Rigo V, Dresse MF. Neonatal Cancer Epidemiology and Outcome: A Retrospective Study. J Pediatr Hematol Oncol. 2020 Jul;42(5):e286-e292. doi: 10.1097/MPH.0000000000001692.
PubMed 31815889Parkes SE, Muir KR, Southern L, Cameron AH, Darbyshire PJ, Stevens MC. Neonatal tumours: a thirty-year population-based study. Med Pediatr Oncol. 1994;22(5):309-17. doi: 10.1002/mpo.2950220503.
PubMed 8127254Alamo L, Beck-Popovic M, Gudinchet F, Meuli R. Congenital tumors: imaging when life just begins. Insights Imaging. 2011 Jun;2(3):297-308. doi: 10.1007/s13244-011-0073-8. Epub 2011 Feb 14.
PubMed 22347954Avni FE, Massez A, Cassart M. Tumours of the fetal body: a review. Pediatr Radiol. 2009 Nov;39(11):1147-57. doi: 10.1007/s00247-009-1160-6. Epub 2009 Feb 24.
PubMed 19238373Orbach D, Sarnacki S, Brisse HJ, Gauthier-Villars M, Jarreau PH, Tsatsaris V, Baruchel A, Zerah M, Seigneur E, Peuchmaur M, Doz F. Neonatal cancer. Lancet Oncol. 2013 Dec;14(13):e609-20. doi: 10.1016/S1470-2045(13)70236-5.
PubMed 24275134Kamil D, Tepelmann J, Berg C, Heep A, Axt-Fliedner R, Gembruch U, Geipel A. Spectrum and outcome of prenatally diagnosed fetal tumors. Ultrasound Obstet Gynecol. 2008 Mar;31(3):296-302. doi: 10.1002/uog.5260.
PubMed 18307207Amari F, Beyer DA, Diedrich K, Weichert J. Fetal intra-abdominal tumors: assessment of spectrum, accuracy of prenatal diagnosis, perinatal outcome and therapy at a tertiary referral center. Eur J Obstet Gynecol Reprod Biol. 2013 Apr;167(2):160-6. doi: 10.1016/j.ejogrb.2012.11.023. Epub 2013 Jan 5.
PubMed 23295072Meizner I. Perinatal oncology--the role of prenatal ultrasound diagnosis. Ultrasound Obstet Gynecol. 2000 Nov;16(6):507-9. doi: 10.1046/j.1469-0705.2000.00297.x. No abstract available.
PubMed 11169341Isaacs H Jr. Fetal hydrops associated with tumors. Am J Perinatol. 2008 Jan;25(1):43-68. doi: 10.1055/s-2007-1004826. Epub 2007 Dec 12.
PubMed 18075961Braun T, Brauer M, Fuchs I, Czernik C, Dudenhausen JW, Henrich W, Sarioglu N. Mirror syndrome: a systematic review of fetal associated conditions, maternal presentation and perinatal outcome. Fetal Diagn Ther. 2010;27(4):191-203. doi: 10.1159/000305096. Epub 2010 Mar 27.
PubMed 20357423Sauvat F, Sarnacki S, Brisse H, Medioni J, Rubie H, Aigrain Y, Gauthier F, Audry G, Helardot P, Landais P, Michon J, Hartmann O, Nihoul-Fekete C. Outcome of suprarenal localized masses diagnosed during the perinatal period: a retrospective multicenter study. Cancer. 2002 May 1;94(9):2474-80. doi: 10.1002/cncr.10502.
PubMed 12015773Khawand C, Orbach D, Berrebi D, Branchereau S, Mussini C, Brisse HJ, Grevent D, Jouannic JM, Vivanti A, Minard-Colin V, Ville Y, Sarnacki S; Collaborators. Prenatal diagnosis and postnatal management of perinatal thoracoabdominopelvic tumors: multicenter experience. Ultrasound Obstet Gynecol. 2025 Oct;66(4):499-508. doi: 10.1002/uog.70000. Epub 2025 Aug 23.
PubMed 40847681
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Thoraco-abdominal Tumors Management in Infants : a Multicenter Experience
- ClinicalTrials.gov ID
- NCT06365268
- Acronym / sponsor ID
- CONTRAST / APHP231139
- Keywords
- Congenital truncal tumors, Antenatal diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of data from the patient's medical fileMother-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. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Opposition from holders of parental authority of patients
- Sacrococcygeal teratomas
- Central nervous system tumors
- Heart tumors
- Ovarian cysts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of data from the patient's medical fileCollection of data from the patient's medical file. The data collected concerns a period of three years maximum. | Other | Patients |
Primary outcome
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.
Description of the developmental spectrum of solid congenital truncal tumors
Time frame: 3 years
Study of data from the patient's medical file.
6 secondary outcomes
Characteristics and location of the tumor on pre- and post-natal imaging
Time frame: 3 years
Ile-de-France epidemiology of perinatal tumors
Time frame: Through study completion, an average of 4 months
Evolution of solid congenital truncal tumors
Time frame: Through study completion, an average of 4 months
Associated genetic abnormalities and malformations
Time frame: 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
Development of a management algorithm based on prenatal findings
Time frame: Through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 3879355Isaacs H Jr. Perinatal (congenital and neonatal) neoplasms: a report of 110 cases. Pediatr Pathol. 1985;3(2-4):165-216. doi: 10.3109/15513818509078782.
- Background: PubMed 14523568Moore SW, Satge D, Sasco AJ, Zimmermann A, Plaschkes J. The epidemiology of neonatal tumours. Report of an international working group. Pediatr Surg Int. 2003 Sep;19(7):509-19. doi: 10.1007/s00383-003-1048-8. Epub 2003 Sep 11.
- Background: PubMed 31815889Geurten C, Geurten M, Rigo V, Dresse MF. Neonatal Cancer Epidemiology and Outcome: A Retrospective Study. J Pediatr Hematol Oncol. 2020 Jul;42(5):e286-e292. doi: 10.1097/MPH.0000000000001692.
- Background: PubMed 8127254Parkes SE, Muir KR, Southern L, Cameron AH, Darbyshire PJ, Stevens MC. Neonatal tumours: a thirty-year population-based study. Med Pediatr Oncol. 1994;22(5):309-17. doi: 10.1002/mpo.2950220503.
- Background: PubMed 22347954Alamo L, Beck-Popovic M, Gudinchet F, Meuli R. Congenital tumors: imaging when life just begins. Insights Imaging. 2011 Jun;2(3):297-308. doi: 10.1007/s13244-011-0073-8. Epub 2011 Feb 14.
- Background: PubMed 19238373Avni FE, Massez A, Cassart M. Tumours of the fetal body: a review. Pediatr Radiol. 2009 Nov;39(11):1147-57. doi: 10.1007/s00247-009-1160-6. Epub 2009 Feb 24.
- Background: PubMed 24275134Orbach D, Sarnacki S, Brisse HJ, Gauthier-Villars M, Jarreau PH, Tsatsaris V, Baruchel A, Zerah M, Seigneur E, Peuchmaur M, Doz F. Neonatal cancer. Lancet Oncol. 2013 Dec;14(13):e609-20. doi: 10.1016/S1470-2045(13)70236-5.
- Background: PubMed 18307207Kamil D, Tepelmann J, Berg C, Heep A, Axt-Fliedner R, Gembruch U, Geipel A. Spectrum and outcome of prenatally diagnosed fetal tumors. Ultrasound Obstet Gynecol. 2008 Mar;31(3):296-302. doi: 10.1002/uog.5260.
- Background: PubMed 23295072Amari F, Beyer DA, Diedrich K, Weichert J. Fetal intra-abdominal tumors: assessment of spectrum, accuracy of prenatal diagnosis, perinatal outcome and therapy at a tertiary referral center. Eur J Obstet Gynecol Reprod Biol. 2013 Apr;167(2):160-6. doi: 10.1016/j.ejogrb.2012.11.023. Epub 2013 Jan 5.
- Background: PubMed 11169341Meizner I. Perinatal oncology--the role of prenatal ultrasound diagnosis. Ultrasound Obstet Gynecol. 2000 Nov;16(6):507-9. doi: 10.1046/j.1469-0705.2000.00297.x. No abstract available.
- Background: PubMed 18075961Isaacs H Jr. Fetal hydrops associated with tumors. Am J Perinatol. 2008 Jan;25(1):43-68. doi: 10.1055/s-2007-1004826. Epub 2007 Dec 12.
- Background: PubMed 20357423Braun T, Brauer M, Fuchs I, Czernik C, Dudenhausen JW, Henrich W, Sarioglu N. Mirror syndrome: a systematic review of fetal associated conditions, maternal presentation and perinatal outcome. Fetal Diagn Ther. 2010;27(4):191-203. doi: 10.1159/000305096. Epub 2010 Mar 27.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine SARNACKI, M.D., PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Chelsea KHAWAND, M.D. study director
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06365268, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.