Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s) (PRURI-C)

Study on the Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)

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).

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Pruritus

Detailed 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)

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Service de dermatologie, CHRU BREST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who are seen in radiotherapy consultation and / or hospitalization of neurosurgery Fulfilling the inclusion criteria, not falling within the exclusion criteria 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): September 5, 2021
• Study Completion (Actual): September 5, 2021

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Skin Manifestations; Brain Neoplasms; Pruritus
• Other Study ID Numbers: 29BRC18.0155

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No