Lanugo Hair Loss as a Marker for Peri-ocular Malignancy

NCT ID: NCT03382704

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Cancer Face

Keywords

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Peri-ocular

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing biopsy

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

Examination for presence or absence of lanugo hairs

Intervention Type DIAGNOSTIC_TEST

Pre-operative examination for presence or absence of lanugo hairs

Interventions

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Examination for presence or absence of lanugo hairs

Pre-operative examination for presence or absence of lanugo hairs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients undergoing biopsy for peri-ocular lesion

Exclusion Criteria

* Age under 18; previous biopsy or excision on the same lid
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Robert Peden

OTHER_GOV

Sponsor Role lead

Responsible Party

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Robert Peden

Speciality Registrar

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert G Peden, MA; MBBS

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

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Princess Alexandra Eye Pavilion

Edinburgh, Midlothian, United Kingdom

Site Status

Moorfields Eye Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Robert G Peden, MA; MBBS

Role: CONTACT

Phone: 01315361000

Email: [email protected]

Facility Contacts

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Robert G Peden, MA; MBBS

Role: primary

Mark R Wright

Role: backup

Hannah Timlin

Role: primary

Other Identifiers

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229755

Identifier Type: -

Identifier Source: org_study_id