Sacrococcygeal Teratoma Clinical Trial
— CurrarinoOfficial title:
Characterization of At-risk Population and Prognosis Factors for SACRO-coccygeal Teratoma in CURRARINO Syndrome. A Clinical, Molecular and Pathological Study.
Verified date | July 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
Contribute to support hypothesis of relationships between genes involve in oncogenesis and those involve in embryological development.
Status | Completed |
Enrollment | 57 |
Est. completion date | December 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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: - Opposition to sign informed consent agreement |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker-Enfants Malades Pediatric Surgery Department | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annual lumbar-sacral MRI is performed | one year | No | |
Secondary | Pathological tumoral tissue analysis after surgical removal | 3 years | No | |
Secondary | Annual serum alpha-foeto protein level monitoring | one year | No |
Status | Clinical Trial | Phase | |
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