Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma

Study Purpose

Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach.

Exclusion Criteria:

- Patient with NF2.

- Patient previuosly treated with RT in the head and neck district.

- Patient with pre-treatment facial palsy ipsi and controlateral.

- Patient non native italian speakers.

- Patient with major mental illness already existing before the acoustic neuroma diagnosis.

- Patient with neurological issues such as chronic migraine or postural instability already existing before the acoustic neuroma diagnosis

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06844461
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Quality of Life Outcomes, Acoustic Schwannoma

Arms & Interventions

Arms

: Wait-and-scan cohort

Clinico-radiological follow-up with annual brain MRI to detect increase of volume and size of the tumor

: Surgery cohort

Surgical cohort with tumor excision through any possible approach to lateral skull base

Interventions

Contact a Trial Team

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International Sites

Irccs Aou Bologna, Bologna, Italy

Status

Recruiting

Address

Irccs Aou Bologna

Bologna, , 40138

Site Contact

Cecilia Botti

[email protected]

+39 0512143266

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