Hemangioblastoma (HB) of the Central Nervous System (CNS)PsychoVHLNCT02120040
Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System
A study testing evaluation of anxiety with psychosocial scales in people with Hemangioblastoma (HB) of the Central Nervous System (CNS), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemangioblastoma (HB) of the Central Nervous System (CNS)
- What is being tested?
- evaluation of anxiety with psychosocial scales
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2014to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- minor,
- incorrect French language
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- evaluation of anxiety with psychosocial scales
- Medical subject headings
- Hemangioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of anxiety with psychosocial scalesOther
| Study group | Role | What they receive |
|---|---|---|
| Hemangioblastoma (HB) of the Central nervous system (CNS) | Other | Not described Receives: Other: evaluation of anxiety with psychosocial scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Secondary outcomes (1)
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study start2 May 2014
- Primary completion9 Oct 2015
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemangioblastoma (HB) of the Central Nervous System (CNS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Metellus, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120040
- Sponsor's protocol ID
- 2014-01
- Acronym
- PsychoVHL
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2014
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System
- ClinicalTrials.gov ID
- NCT02120040
- Acronym / sponsor ID
- PsychoVHL / 2014-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 May 2014 (actual)
- Primary completion
- 9 Oct 2015 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemangioblastoma (HB) of the Central nervous system (CNS) | Other | Other: evaluation of anxiety with psychosocial scales |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- minor,
- incorrect French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of anxiety with psychosocial scales | Other | Hemangioblastoma (HB) of the Central nervous system (CNS) |
Primary outcome
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
1 secondary outcome
assessment of the mood
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Related trials for Hemangioblastoma (HB) of the Central Nervous System (CNS)
RecruitingPhase 2
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
Von Hippel Lindau, Von Hippel Lindau Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Metellus, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of anxiety with psychosocial scales in people with Hemangioblastoma (HB) of the Central Nervous System (CNS), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the impact on anxiety of VHL mutation screening of patients operated for HB (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.