- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03382704
Vellus Hair Loss as a Marker for Peri-ocular Malignancy
Skin cancers around the eye are common, but so are other lid lumps. It is useful to be able to tell which lumps are likely to be cancer.
This study looks at whether the loss of fine hairs (vellus hairs) on the skin are a good indicator of whether a lump is a skin cancer or not.
The investigators are recruiting patients who have lid lumps who haven't had a biopsy before, who would be having a biopsy as part of their treatment, and seeing whether those who have loss of the fine skin hairs are the same as those who have skin cancer confirmed on their biopsy.
The study doesn't involve any extra examinations or treatments for participants. The investigators look at the patients before the biopsy as part of their usual care, and take a note of whether or not they have lost the fine hairs at this stage.
The main benefit of participating is that the medical community has better evidence about which lid lumps are likely to represent skin cancer, helping future diagnosis.
There are no additional risks to participating. The risks of biopsy are unchanged whether patients participate in the study or not.
The study is run from the Princess Alexandra Eye Pavilion in Edinburgh.
The investigators aim to start the study in Spring 2020, and will most likely recruit for 6 months depending on the number of participants recruited.
There is no additional funding from any source at present - the work will be undertaken by doctors in their research time.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Contacts and Locations
Study Locations
-
-
Midlothian
-
Edinburgh, Midlothian, United Kingdom, EH3 9HA
- Princess Alexandra Eye Pavilion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients undergoing biopsy for peri-ocular lesion
Exclusion Criteria:
- Age under 18; previous biopsy or excision on the same lid
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients undergoing biopsy
Patients undergoing biopsy (incisional or excisional) of peri-ocular lesions.
Pre-operative examination for presence or absence of vellus hairs
|
Pre-operative examination for presence or absence of vellus hairs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vellus hair presence/absence
Time Frame: Day 1
|
Examination for the presence or absence of vellus hairs prior to biopsy
|
Day 1
|
|
Biopsy result
Time Frame: On receipt of biopsy result from pathology lab (~1 week)
|
Biopsy result looking for malignancy
|
On receipt of biopsy result from pathology lab (~1 week)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert G Peden, MA; MBBS; FRCOphth, NHS Lothian
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 229755
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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