Moletest Clinical Study in Scotland | NCT02196246

Studies
Moletest Clinical Study in Scotland

NCT02196246

Sponsor

Moletest Scotland Ltd

Status

Completed

Last Update Posted

Dec 4, 2017Actual

Enrollment

1,120Actual

Phase

Not provided

Conditions

Melanoma

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2015Actual

Primary Completion Date

Oct 12, 2016Actual

Completion Date

May 31, 2017Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 21, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2017

Last Update Posted Date

Dec 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Girish Gupta, Principal Investigator Scientic Advisory Board member, Moletest Scotland LtdPrincipal Investigator

Lead Sponsor

Moletest Scotland LtdINDUSTRY

Collaborators

Name	Class
Digital Health & Care Institute	OTHER
NHS Lanarkshire	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion	The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later	6 weeks turnaround for each sample

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent

Exclusion Criteria:

There is no exclsion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients referred to the Dermatology Department, Lanarkshire Hospitals for assessment of suspicious skin lesions are eligible for inclusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Freedman	Royal College of Physicians	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Lanarkshire R&D		Airdrie		ML6 0JS	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided