NCT02120040: PsychoVHL

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

Completed NA Last updated 6 April 2023

What this trial tests

NA trial testing evaluation of anxiety with psychosocial scales in Hemangioblastoma (HB) of the Central Nervous System (CNS) in 42 participants. Completed in 8 March 2023.

Timeline

2 May 2014

Primary endpoint
9 October 2015

8 March 2023

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	42
Start date	2 May 2014
Primary completion	9 October 2015
Estimated completion	8 March 2023
Sites	1 location across France

Drugs / interventions tested

• evaluation of anxiety with psychosocial scales

Conditions studied

• Hemangioblastoma (HB) of the Central Nervous System (CNS) — all drugs for Hemangioblastoma (HB) of the Central Nervous System (CNS) →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 18 to 80, any sex, with Hemangioblastoma (HB) of the Central Nervous System (CNS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Psychological impact of von Hippel-Lindau genetic screening in patients with a previous history of hemangioblastoma of the central nervous system.
   Rochette C, Baumstarck K, Canoni-Zattara H, Abdullah AE, et al · · 2018 · cited 5× · PMID 29764331 · DOI 10.1080/07347332.2018.1450320