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

NCT02120040 | Completed

• 1 other identifier: 2014-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemangioblastoma (HB) of the Central Nervous System (CNS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assessment of the mood

  two years

Other Outcomes (2)

• assesment of quality of life

  two years

• assesment of the psychological consequences of the screening

  two years

Study Arms (1)

Hemangioblastoma (HB) of the Central nervous system (CNS)

OTHER

Other: evaluation of anxiety with psychosocial scales

Interventions

evaluation of anxiety with psychosocial scales OTHER

Hemangioblastoma (HB) of the Central nervous system (CNS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• minor,
• incorrect French language

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

Hemangioblastoma

Condition Hierarchy (Ancestors)

Hemangioma, Capillary; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Philippe Metellus, MD

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 22, 2014
• Study Start: May 2, 2014
• Primary Completion: October 9, 2015
• Study Completion: March 8, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

FR (1)