Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-08 @ 3:52 AM
Study NCT ID:
NCT03382704
Status:
UNKNOWN
Last Update Posted:
2017-12-26
First Post:
2017-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lanugo Hair Loss as a Marker for Peri-ocular Malignancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Pathology samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lanugo hair presence/absence', 'timeFrame': 'Examination on day of biopsy', 'description': 'Examination for the presence or absence of lanugo hairs prior to biopsy'}, {'measure': 'Biopsy result', 'timeFrame': 'Typically reported within a week of biopsy', 'description': 'Biopsy result looking for malignancy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-ocular'], 'conditions': ['Skin Cancer Face']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThere are no additional risks to participating. The risks of biopsy are unchanged whether patients participate in the study or not.\n\nThe study is run from the Princess Alexandra Eye Pavilion in Edinburgh, in conjunction with Moorfields Eye Hospital, London\n\nThe investigators aim to start the study in Spring 2018, and will most likely recruit for 6 months depending on the number of participants recruited.\n\nThere is no additional funding from any source at present - the work will be undertaken by doctors in their research time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All cases undergoing incision or excision biopsy of peri-ocular lesions at the two participating centres', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing biopsy for peri-ocular lesion\n\nExclusion Criteria:\n\n* Age under 18; previous biopsy or excision on the same lid'}, 'identificationModule': {'nctId': 'NCT03382704', 'briefTitle': 'Lanugo Hair Loss as a Marker for Peri-ocular Malignancy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Lothian'}, 'officialTitle': 'Lanugo Hair Loss as a Marker for Peri-ocular Malignancy', 'orgStudyIdInfo': {'id': '229755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing biopsy', 'description': 'Patients undergoing biopsy (incisional or excisional) of peri-ocular lesions. Pre-operative examination for presence or absence of lanugo hairs', 'interventionNames': ['Diagnostic Test: Examination for presence or absence of lanugo hairs']}], 'interventions': [{'name': 'Examination for presence or absence of lanugo hairs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pre-operative examination for presence or absence of lanugo hairs', 'armGroupLabels': ['Patients undergoing biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH3 9HA', 'city': 'Edinburgh', 'state': 'Midlothian', 'country': 'United Kingdom', 'contacts': [{'name': 'Robert G Peden, MA; MBBS', 'role': 'CONTACT', 'email': 'Robert.peden@nhslothian.scot.nhs.uk', 'phone': '01315361000'}, {'name': 'Mark R Wright', 'role': 'CONTACT', 'email': 'Mark.wright@luht.scot.nhs.uk', 'phone': '01315361000'}], 'facility': 'Princess Alexandra Eye Pavilion', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EC1V 2PD', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Hannah Timlin', 'role': 'CONTACT', 'email': 'Hannahtimlin@nhs.net', 'phone': '020 7253 3411'}], 'facility': 'Moorfields Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Robert G Peden, MA; MBBS', 'role': 'CONTACT', 'email': 'Robert.peden@nhslothian.scot.nhs.uk', 'phone': '01315361000'}], 'overallOfficials': [{'name': 'Robert G Peden, MA; MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lothian'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Peden', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Moorfields Eye Hospital NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Speciality Registrar', 'investigatorFullName': 'Robert Peden', 'investigatorAffiliation': 'NHS Lothian'}}}}