NCT03673878

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

August 14, 2018

Last Update Submit

January 12, 2022

Conditions

Outcome Measures

Primary Outcomes (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).

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Age \> 18 years
  • Diagnosis of benign or malignant brain tumor, primary or secondary.
  • Accepted non-opposition
  • Realization of a cerebral MRI (cMRI)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de dermatologie, CHRU BREST

Brest, 29200, France

Location

MeSH Terms

Conditions

PruritusBrain Neoplasms

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

September 17, 2018

Study Start

June 29, 2020

Primary Completion

September 5, 2021

Study Completion

September 5, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations