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Clinical Trials/NCT07275099
NCT07275099
Not yet recruiting
Not Applicable

Quality of Life, Psychological Impact and Care-related Challenges in Patients Affected by Von Hippel-Lindau Syndrome: a Single-centre Observational, Transversal, Study.

IRCCS Ospedale San Raffaele0 sites200 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
IRCCS Ospedale San Raffaele
Enrollment
200
Primary Endpoint
Completion of a self- administered questionnaire

Overview

Brief Summary

This is a single-centre, cross-sectional observational study aiming to assess the psychological burden, quality of life, and perceived barriers to care in patients with von Hippel-Lindau syndrome (VHL). Data will be collected through an anonymous online questionnaire, specifically designed for the study and administered via Google Forms.

Detailed Description

This is a single-centre, cross-sectional observational study designed to assess the psychological burden and health-related quality of life in individuals with von Hippel-Lindau (VHL) syndrome, and to explore perceived barriers to healthcare access and the perceived adequacy of multidisciplinary care.

The hypothesis underlying this study is that individuals affected by VHL experience a substantial psychological burden and face variable access to appropriate care pathways, which may differ based on demographic or clinical factors.

The study will involve a single group of participants (n ≈ 200). No control group or randomization is foreseen. The study duration is estimated at 10 years, including data collection and analysis.

Each participant will be involved once, with a single data collection session (approx. 25-30 minutes) through the study-specific questionnaire "VHL: Accesso alle cure e vita quotidiana". The questionnaire, administered in Italian via the Google Forms platform, is not part of routine clinical practice and is administered exclusively for research purposes.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years
  • Genetically confirmed diagnosis of von Hippel- Lindau syndrome

Exclusion Criteria

  • Inability to understand or complete the questionnaire, either independently or with assistance

Arms & Interventions

Single - centre, cross - sectional observational study with additional procedure.

Adult subjects (≥ 18 years) with confirmed diagnosis of von Hippel - Lindau syndrome

Outcomes

Primary Outcomes

Completion of a self- administered questionnaire

Time Frame: Single time point (approximately 25-30minutes).

The research activity consists in the anonymous collection of patient- reported data through an online questionnaire. No diagnostic, therapeutic, or experimental interventions are foreseen. The study fully complies with the definition of non-interventional observational research.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
IRCCS Ospedale San Raffaele
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Larcher Alessandro

Medical Doctor

IRCCS Ospedale San Raffaele

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