Hemangioblastoma (HB) of the Central Nervous System (CNS) Clinical Trial
— PsychoVHL| NCT number | NCT02120040 |
| Other study ID # | 2014-01 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2, 2014 |
| Est. completion date | March 8, 2023 |
| Verified date | April 2023 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost complete penetrance) that predisposes to many tumors including some associated with a poorer outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality. The diagnosis of VHL disease may be challenging because tumors have an asynchronous and multi-organ development and there is often no apparent hereditary context. As it is admitted that VHL disease is underdiagnosed, some countries have decided to recall patients presenting one of the potentially VHL disease-associated tumors to screen them for VHL mutation. Screening is currently recommended in guidelines but many patients may have not been previously screened. Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population enables the diagnosis of other tumor types at an early stage of development since HB is chronologically the second tumor occurring during the VHL disease history. But it raises critical problems and questions: difficult announcement of a potentially severe disease and psychosocial dimension related to inheritance of the disease.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | March 8, 2023 |
| Est. primary completion date | October 9, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - age >=18; - Surgery for a CNS HB in the department of Neurosurgery of la Timone university hospital since 1999 ; - Absence of prior screening for VHL Exclusion Criteria: - minor, - incorrect French language |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | assesment of quality of life | The measure of the quality of life will be made by means of a generic questionnaire: the SF36. The SF36, used for the evaluation of the remote quality of life of the plan of announcement, is validated and available in French language | two years | |
| Other | assesment of the psychological consequences of the screening | The psychological consequences of the screening will be estimated by means of Psychological Consequences Questionnaire . It is about a specific instrument allowing to estimate the psychosocial impact of the screening | two years | |
| Primary | evaluate the impact on anxiety of VHL mutation screening of patients operated for HB | The main objective of this study is to evaluate the impact on anxiety of VHL mutation screening of patients operated for HB | two years | |
| Secondary | assessment of the mood | The evaluation of the mood will be made from Beck's scale. It is about a scale allowing to make a fast self-assessment of the depression | two years |