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Lanugo Hair Loss as a Marker for Peri-ocular Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382704
Recruitment Status : Unknown
Verified December 2017 by Robert Peden, NHS Lothian.
Recruitment status was:  Not yet recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Moorfields Eye Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Robert Peden, NHS Lothian

Study Description
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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 (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.


Condition or disease Intervention/treatment
Skin Cancer Face Diagnostic Test: Examination for presence or absence of lanugo hairs

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lanugo Hair Loss as a Marker for Peri-ocular Malignancy
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Skin Cancer

Groups and Cohorts
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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 lanugo hairs
 Diagnostic Test: Examination for presence or absence of lanugo hairs
Pre-operative examination for presence or absence of lanugo hairs


Outcome Measures
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Primary Outcome Measures :
  1. Lanugo hair presence/absence [ Time Frame: Examination on day of biopsy ]
    Examination for the presence or absence of lanugo hairs prior to biopsy

  2. Biopsy result [ Time Frame: Typically reported within a week of biopsy ]
    Biopsy result looking for malignancy


Biospecimen Retention:   None Retained
Pathology samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All cases undergoing incision or excision biopsy of peri-ocular lesions at the two participating centres
Criteria

Inclusion Criteria:

  • patients undergoing biopsy for peri-ocular lesion

Exclusion Criteria:

  • Age under 18; previous biopsy or excision on the same lid
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382704


Contacts
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Contact: Robert G Peden, MA; MBBS 01315361000 Robert.peden@nhslothian.scot.nhs.uk

Locations
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United Kingdom
Princess Alexandra Eye Pavilion
Edinburgh, Midlothian, United Kingdom, EH3 9HA
Contact: Robert G Peden, MA; MBBS    01315361000    Robert.peden@nhslothian.scot.nhs.uk   
Contact: Mark R Wright    01315361000    Mark.wright@luht.scot.nhs.uk   
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Contact: Hannah Timlin    020 7253 3411    Hannahtimlin@nhs.net   
Sponsors and Collaborators
Robert Peden
Moorfields Eye Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Robert G Peden, MA; MBBS NHS Lothian
More Information
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Responsible Party: Robert Peden, Speciality Registrar, NHS Lothian
ClinicalTrials.gov Identifier: NCT03382704    
Other Study ID Numbers: 229755
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Peden, NHS Lothian:
Peri-ocular
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases