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

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03673878
Collaborator
(none)
200
Enrollment
1
Location
14.2
Actual Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on the Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)
    Actual Study Start Date :
    Jun 29, 2020
    Actual Primary Completion Date :
    Sep 5, 2021
    Actual Study Completion Date :
    Sep 5, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de dermatologie, CHRU BREST Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03673878
    Other Study ID Numbers:
    • 29BRC18.0155
    First Posted:
    Sep 17, 2018
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Neoplasms
    Pruritus

    Study Results

    No Results Posted as of Jan 27, 2022