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Trial record 7 of 8 for:    Open Studies | "von Hippel-Lindau Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02120040
First received: April 16, 2014
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: April 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120040

Contacts
Contact: Philippe METELLUS, MD 33191385541 pmetellus@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Philippe Metellus, MD    0491385541    pmetellus@ap-hm.fr   
Principal Investigator: Philippe metellus, md         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Philippe Metellus, MD Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02120040     History of Changes
Other Study ID Numbers: 2014-01
Study First Received: April 16, 2014
Last Updated: April 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Von Hippel-Lindau Disease
Hemangioblastoma
Angiomatosis
Cardiovascular Diseases
Hemangioma
Hemangioma, Capillary
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Nervous System Diseases
Neurocutaneous Syndromes
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014