Lanugo Hair Loss as a Marker for Peri-ocular Malignancy

Skin Cancer Face Clinical Trial

Official title:

Lanugo Hair Loss as a Marker for Peri-ocular Malignancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03382704
• Other study ID #: 229755
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 18, 2017
• Start date: April 2018
• Est. completion date: October 2018

Study information

• Verified date: December 2017
• Source: NHS Lothian
• Contact: Robert G Peden, MA; MBBS
• Phone: 01315361000
• Email: Robert.peden[@]nhslothian.scot.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 (lanugo 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, in conjunction with Moorfields Eye Hospital, London

The investigators aim to start the study in Spring 2018, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing biopsy for peri-ocular lesion

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Skin Cancer Face
• Skin Neoplasms

Intervention

Diagnostic Test:
• Examination for presence or absence of lanugo hairs
Pre-operative examination for presence or absence of lanugo hairs

Locations

Country	Name	City	State
United Kingdom	Princess Alexandra Eye Pavilion	Edinburgh	Midlothian
United Kingdom	Moorfields Eye Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Robert Peden	Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lanugo hair presence/absence	Examination for the presence or absence of lanugo hairs prior to biopsy	Examination on day of biopsy
Primary	Biopsy result	Biopsy result looking for malignancy	Typically reported within a week of biopsy