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CURRARINO SyndromeCurrarinoNCT00780117

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

An observational study of CURRARINO Syndrome and Sacrococcygeal Teratoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Contribute to support hypothesis of relationships between genes involve in oncogenesis and those involve in embryological development. Read more about this study

Who is it for?
Any age
How many people
57 participants
Where
1 siteFrance
Study dates
Jun 2008to Dec 2011
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: specialized consultations in the currarino syndrom network

Who may be able to join

  • At least 1 out of the 4 major signs of CURRARINO syndrome:
  • Sacral agenesis
  • Hindgut malformation or chronic constipation
  • Presacral tumor and/or
  • TETHECORD syndrome and/or lipoma of the filum or the conus
  • Anomaly genotyping HLXB9 without clinical expression

Who cannot join

  • Opposition to sign informed consent agreement

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital Necker-Enfants Malades Pediatric Surgery Department

    Paris, 75015

Other trials in France

About this study

Official title: Characterization of At-risk Population and Prognosis Factors for SACRO-coccygeal Teratoma in CURRARINO Syndrome. A Clinical, Molecular and Pathological Study.

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.

Keywords
CURRARINO syndrome, Sacrococcygeal teratoma, HLXB9 (MNX1) gene, Alpha foeto protein, Prognosis factors
Medical subject headings
Currarino triad

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annual lumbar-sacral MRI is performed

    Measured: one year

Secondary outcomes (2)
  1. Pathological tumoral tissue analysis after surgical removal

    Measured: 3 years

  2. Annual serum alpha-foeto protein level monitoring

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJun 2011
  4. Study completionDec 2011

Resources

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
Prospective
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00780117
Sponsor's protocol ID
P070305
Acronym
Currarino
Status last verified
Mar 2026
First submitted
24 Oct 2008
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of CURRARINO Syndrome and 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 6 inclusion and 1 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 31 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?

Annual lumbar-sacral MRI is performed (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Mar 2026.

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