Sacrococcygeal TeratomaPROSTEONCT04623658
Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma
An observational study of Sacrococcygeal Teratoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Sacrococcygeal Teratoma
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2020to 30 Apr 2021
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Fetuses and infants (< 1 year) diagnosed with benign sacrococcygeal teratoma
- Cared for between January 2007 and December 2017 in the participating centers
Who cannot join
- Currarino syndrome
- Other benign sacrococcygeal teratoma discovered after 1 year old or malignant sacrococcygeal tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma: a Multicenter Retrospective Study With Review of the Literature
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.
Read the detailed description
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:
- 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
- A risk of benign or malignant tumor recurrence
- 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.
- Conditions
- Sacrococcygeal Teratoma
- Keywords
- Sacrococcygeal teratoma, Prenatal diagnosis, Prenatal counseling, Prognostic factors, Neonatal tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of postnatal sequelae
Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae
Measured: Up to 10 years
Fetal or neonatal death
Intrauterine fetal death, termination of pregnancy or neonatal death
Measured: Before 28 days of life
Occurrence of benign or malignant recurrence
Relapse requiring subsequent surgical procedures and/or chemotherapy
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start30 Nov 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacrococcygeal TeratomaStudies 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
- 84 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, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisNicolas Vinit, Resident, MSc, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623658
- Sponsor's protocol ID
- APHP200355
- Acronym
- PROSTEO
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vinit N, Bonnard A, Irtan S, Fouquet V, Ville Y, Rosenblatt J, Jouannic JM, Benachi A, Khen-Dunlop N, Lapillonne A, Beaudoin S, Rousseau V, Salomon LJ, Sarnacki S. Perinatal Prognostic Factors of Recurrence or Functional Sequelae in Neonatal Sacrococcygeal Teratoma, and Implications for Prenatal Counselling: A Multicenter Retrospective Study. J Pediatr Surg. 2025 Dec;60(12):162687. doi: 10.1016/j.jpedsurg.2025.162687. Epub 2025 Sep 17.
PubMed 40972984Vinit N, Benachi A, Rosenblatt J, Jouannic JM, Rousseau V, Bonnard A, Irtan S, Fouquet V, Ville Y, Khen-Dunlop N, Lapillonne A, Jais JP, Beaudoin S, Salomon LJ, Sarnacki S. Growth velocity of fetal sacrococcygeal teratoma as predictor of perinatal morbidity and mortality: multicenter study. Ultrasound Obstet Gynecol. 2024 Nov;64(5):651-660. doi: 10.1002/uog.29110.
PubMed 39482803
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma: a Multicenter Retrospective Study With Review of the Literature
- ClinicalTrials.gov ID
- NCT04623658
- Acronym / sponsor ID
- PROSTEO / APHP200355
- Conditions
- Sacrococcygeal Teratoma
- Keywords
- Sacrococcygeal teratoma, Prenatal diagnosis, Prenatal counseling, Prognostic factors, Neonatal tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 10 Nov 2020 (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.
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.
Detailed description
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:
- 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
- A risk of benign or malignant tumor recurrence
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (2 listed)
- Fetuses and infants (< 1 year) diagnosed with benign sacrococcygeal teratoma
- Cared for between January 2007 and December 2017 in the participating centers
Key exclusion criteria (2 listed)
- Currarino syndrome
- Other benign sacrococcygeal teratoma discovered after 1 year old or malignant sacrococcygeal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of postnatal sequelae
Time frame: Up to 10 years
Presence of digestive, urinary, cosmetic or psychologic postnatal sequelae
Fetal or neonatal death
Time frame: Before 28 days of life
Intrauterine fetal death, termination of pregnancy or neonatal death
Occurrence of benign or malignant recurrence
Time frame: Up to 10 years
Relapse requiring subsequent surgical procedures and/or chemotherapy
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 9 Mar 2026.
- Results publication: PubMed 40972984Vinit N, Bonnard A, Irtan S, Fouquet V, Ville Y, Rosenblatt J, Jouannic JM, Benachi A, Khen-Dunlop N, Lapillonne A, Beaudoin S, Rousseau V, Salomon LJ, Sarnacki S. Perinatal Prognostic Factors of Recurrence or Functional Sequelae in Neonatal Sacrococcygeal Teratoma, and Implications for Prenatal Counselling: A Multicenter Retrospective Study. J Pediatr Surg. 2025 Dec;60(12):162687. doi: 10.1016/j.jpedsurg.2025.162687. Epub 2025 Sep 17.
- Results publication: PubMed 39482803Vinit N, Benachi A, Rosenblatt J, Jouannic JM, Rousseau V, Bonnard A, Irtan S, Fouquet V, Ville Y, Khen-Dunlop N, Lapillonne A, Jais JP, Beaudoin S, Salomon LJ, Sarnacki S. Growth velocity of fetal sacrococcygeal teratoma as predictor of perinatal morbidity and mortality: multicenter study. Ultrasound Obstet Gynecol. 2024 Nov;64(5):651-660. doi: 10.1002/uog.29110.
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, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Nicolas Vinit, Resident, MSc study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacrococcygeal Teratoma, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 inclusion and 2 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Presence of postnatal sequelae (time frame: Up to 10 years). The study lists 3 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 NCT04623658, which also lists 2 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 9 Mar 2026.