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CompletedNCT00780117CurrarinoUpdated Mar 31, 2026

Characterization of At-risk Population for Pre-sacral Tumor in CURRARINO Syndrome

An observational study in CURRARINO Syndrome, Sacrococcygeal Teratoma and Presacral Mass, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
57
Sex
All
01

Study summary

Contribute to support hypothesis of relationships between genes involve in oncogenesis and those involve in embryological development.

Read the detailed description

CURRARINO syndrome (CS) (OMIM 176450) is a rare congenital disease described in 1981, as the association of, at least, three main clinical features: typical sacral malformation (sickled-shape sacrum or total sacral agenesis below S2), hindgut anomalies and pre-sacral tumor. To date, neurological defects, as tethered cord and/or lipoma of the filum or the conus, are up lighted to be as a fourth major clinical sign.In half of cases, CS is ascribed to heterozygous mutations of the HLXB9 gene (or MNX1 gene, OMIM 142994) located at 7q36, with an autosomal dominant mode of inheritance. The HLXB9 gene is involved in motoneurons and caudal development of the embryo. However, genetic heterogeneity is suspected, since patients without HLXB9 mutation harbour subtle phenotypic variations. Presently, no other locus has been identified. The pre-sacral tumor develops in almost 80% of CS. When it is a teratoma (30% of cases), it may turn into malignancy in 1 to 4 % of cases, according to literature. As far as we know, no clinical, molecular or pathological marker is operational to predict tumoral evolution and give any prognosis. Major aim of this study is to find out any correlation between clinical signs, constitutional and somatic genetic anomalies of HLXB9 gene and other candidate genes, and/or pathological features and tumoral evolution in CS. Evaluation of the pre-sacral tumor evolution is based on local recurrence or distance metastasis after surgical removal. Annual serum alpha-foeto-protein level monitoring is also performed, as the unique marker of teratoma.This study specifically required annual clinical examination and lumbar-sacral MRI imaging, three blood samples at inclusion and an annual blood sample.This multicentric study will last for at least 6 years. Eighty patients will be included and follow up for at least 3 years. Finally, this study may help identify a group of at-risk patients for tumor development and malignant transformation if pre-sacral teratoma. It will also help define objective clinical, radiological, molecular, pathological and/or biological criteria for long lasting survey. In general, it may also contribute to support hypothesis of close relationships between genes involve in oncogenesis and those involve in embryological development.

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Conditions studied

  • CURRARINO Syndrome
  • Sacrococcygeal Teratoma
  • Presacral Mass

Keywords

  • CURRARINO syndrome
  • Sacrococcygeal teratoma
  • HLXB9 (MNX1) gene
  • Alpha foeto protein
  • Prognosis factors
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In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

specialized consultations in the currarino syndrom network

Inclusion criteria

  • At least 1 out of the 4 major signs of CURRARINO syndrome:

    1. Sacral agenesis
    2. Hindgut malformation or chronic constipation
    3. Presacral tumor and/or
    4. TETHECORD syndrome and/or lipoma of the filum or the conus
  • Anomaly genotyping HLXB9 without clinical expression

Exclusion criteria

Exclusion Criteria:

- Opposition to sign informed consent agreement

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
57 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Annual lumbar-sacral MRI is performed

    Time frame: one year

Secondary outcomes

  1. Pathological tumoral tissue analysis after surgical removal

    Time frame: 3 years

  2. Annual serum alpha-foeto protein level monitoring

    Time frame: one year

07

Study locations

1 site
  • Hôpital Necker-Enfants Malades Pediatric Surgery Department
    Paris, 75015, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00780117
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Oct 27, 2008
Start date
Jun 2008
Primary completion
Jun 2011
Completion
Dec 2011
Last update
Mar 31, 2026

Study contacts

Celia CRETOLLE, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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