The Impact of Melanoma and Drug Treatment in the Real World

March 16, 2023 updated by: Mark Larkin, Vitaccess Ltd
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

819

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults (age ≥18 years) with melanoma of any stage, who are resident in the UK, with NHS or CHI number, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet.

Description

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.

Exclusion Criteria:

  • no specific exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQL), general
Time Frame: Monthly throughout 4 year study duration
EQ-5D-5L
Monthly throughout 4 year study duration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQL), oncology
Time Frame: Monthly throughout 4 year study duration
QLQ-C30
Monthly throughout 4 year study duration
Health-Related Quality of Life (HRQL), symptoms
Time Frame: Monthly throughout 4 year study duration
PRO-CTCAE
Monthly throughout 4 year study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitaccess Ltd

Collaborators

Royal Marsden NHS Foundation Trust
Melanoma UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

December 6, 2021

Study Completion (Actual)

December 6, 2021

Study Registration Dates

First Submitted

December 8, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5100-01-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregated data research dashboards will be available via industry subscriptions or free academic access.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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