The Impact of Melanoma and Drug Treatment in the Real World

NCT ID: NCT03379454

Last Updated: 2023-03-21

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

COMPLETED

Total Enrollment

819 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-25

Study Completion Date

2021-12-06

Brief Summary

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An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the knowledge of melanoma and improve patient care.

Detailed Description

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The registry uses Vitaccess' digital real-world evidence platform, and has been developed in collaboration with the patient advocacy group Melanoma UK.

Eligible participants install a study app on their smartphone or tablet. Researchers access aggregated, anonymised data via a cloud-based research portal. The platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to upload electronic documents such as scans, and access an online melanoma community.

The aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location).

State-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. Participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.

Conditions

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Melanoma

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* adults with melanoma of any stage, resident in the UK with National Health Service (NHS) or Community Health Index (CHI) number, aged 18 and over, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melanoma UK

UNKNOWN

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

Vitaccess Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Mark Larkin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark JW Larkin, PhD

Role: PRINCIPAL_INVESTIGATOR

Vitaccess Ltd

Locations

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Vitaccess Ltd

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.vitaccess.com

Digital platform used to support the study

https://vitaccess.com/real-world-evidence/melanoma-uk-dataset/

Research portal via which anonymised data can be made available to approved researchers

Other Identifiers

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5100-01-2017

Identifier Type: -

Identifier Source: org_study_id

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