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Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System (PsychoVHL)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: April 16, 2014
Last updated: November 16, 2015
Last verified: November 2015

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.

Condition Intervention
Hemangioblastoma (HB) of the Central Nervous System (CNS)
Other: evaluation of anxiety with psychosocial scales

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • evaluate the impact on anxiety of VHL mutation screening of patients operated for HB [ Time Frame: two years ]
    The main objective of this study is to evaluate the impact on anxiety of VHL mutation screening of patients operated for HB

Secondary Outcome Measures:
  • assessment of the mood [ Time Frame: two years ]
    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

Other Outcome Measures:
  • assesment of quality of life [ Time Frame: two years ]
    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

  • assesment of the psychological consequences of the screening [ Time Frame: two years ]
    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

Estimated Enrollment: 42
Study Start Date: May 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hemangioblastoma (HB) of the Central nervous system (CNS) Other: evaluation of anxiety with psychosocial scales


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02120040

Assistance Publique Hopitaux de Marseille
Marseille, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: Philippe Metellus, MD Assistance Publique Hopitaux De Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT02120040     History of Changes
Other Study ID Numbers: 2014-01
Study First Received: April 16, 2014
Last Updated: November 16, 2015

Additional relevant MeSH terms:
Von Hippel-Lindau Disease
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neurocutaneous Syndromes
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 22, 2017