Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System (PsychoVHL)
Primary Purpose
Hemangioblastoma (HB) of the Central Nervous System (CNS)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
evaluation of anxiety with psychosocial scales
Sponsored by
About this trial
This is an interventional other trial for Hemangioblastoma (HB) of the Central Nervous System (CNS)
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hemangioblastoma (HB) of the Central nervous system (CNS)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02120040
First Posted
April 16, 2014
Last Updated
April 5, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02120040
Brief Title
Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System
Acronym
PsychoVHL
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2014 (Actual)
Primary Completion Date
October 9, 2015 (Actual)
Study Completion Date
March 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioblastoma (HB) of the Central Nervous System (CNS)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hemangioblastoma (HB) of the Central nervous system (CNS)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
evaluation of anxiety with psychosocial scales
Primary Outcome Measure Information:
Title
evaluate the impact on anxiety of VHL mutation screening of patients operated for HB
Description
The main objective of this study is to evaluate the impact on anxiety of VHL mutation screening of patients operated for HB
Time Frame
two years
Secondary Outcome Measure Information:
Title
assessment of the mood
Description
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
Time Frame
two years
Other Pre-specified Outcome Measures:
Title
assesment of quality of life
Description
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
Time Frame
two years
Title
assesment of the psychological consequences of the screening
Description
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
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Metellus, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System
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