Vellus Hair Loss as a Marker for Peri-ocular Malignancy

NCT03382704 | Withdrawn

• 1 other identifier: 229755
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer Face

Keywords

Peri-ocular

Outcome Measures

Primary Outcomes (2)

• Vellus hair presence/absence

  Examination for the presence or absence of vellus hairs prior to biopsy

  Day 1

• Biopsy result

  Biopsy result looking for malignancy

  On receipt of biopsy result from pathology lab (~1 week)

Study Arms (1)

Patients undergoing biopsy

Patients undergoing biopsy (incisional or excisional) of peri-ocular lesions. Pre-operative examination for presence or absence of vellus hairs

Diagnostic Test: Examination for presence or absence of vellus hairs

Interventions

Examination for presence or absence of vellus hairs DIAGNOSTIC_TEST

Pre-operative examination for presence or absence of vellus hairs

Patients undergoing biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All cases undergoing incision or excision biopsy of peri-ocular lesions at the study institution during the study period

You may qualify if:

• patients undergoing biopsy for peri-ocular lesion

You may not qualify if:

• Age under 18; previous biopsy or excision on the same lid

Sponsors & Collaborators

• NHS Lothian: lead
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Princess Alexandra Eye Pavilion

Edinburgh, Midlothian, EH3 9HA, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Pathology samples

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert G Peden, MA; MBBS; FRCOphth

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 26, 2017
• Study Start: March 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 16, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)