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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03673878
Other study ID # 29BRC18.0155
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2020
Est. completion date September 5, 2021

Study information

Verified date January 2022
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by Andreev et al. in the British Journal of Dermatology published in 1975. No other study has studied this association with a rigorous methodology. The aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).


Description:

- Monocentric prospective observational study - On the inclusion period - Patients who are seen in radiotherapy consultation and / or department of neurosurgery - Complying with the inclusion criteria, not falling within the exclusion criteria - Re-reading of cerebral MRI (cMRI) with precision on the location(s) of the brain tumor(s) according to a predefined anatomic descriptive diagram - Complete the questionnaire by a dermatologist (characteristics of pruritus, brain lesion(s), characteristics of the population)


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 5, 2021
Est. primary completion date September 5, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Age > 18 years - Diagnosis of benign or malignant brain tumor, primary or secondary. - Accepted non-opposition - Realization of a cerebral MRI (cMRI) Exclusion criteria: - Age < 18 years - Absence of cerebral imaging of the cMRI type - Absence of non opposition - Realization of a treatment modifying the brain structure (radiotherapy / surgery)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de dermatologie, CHRU BREST Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of itching for more than 1 week in a patient with one or more brain tumor(s), primary or secondary, benign(s) or malignant(s). Presence of itching for more than 1 week in a patient with one or more brain tumor(s), primary or secondary, benign(s) or malignant(s). 1 year
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