The Impact of Melanoma and Drug Treatment in the Real World

Sponsor

Vitaccess Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03379454

Collaborator

Melanoma UK (Other), Royal Marsden NHS Foundation Trust (Other)

500

Enrollment

Location

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma

Detailed Description

The registry uses Vitaccess' MyRealWorld(tm) 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

The Impact of Melanoma and Drug Treatment in the Real World

Actual Study Start Date :

Oct 25, 2017

Anticipated Primary Completion Date :

Oct 25, 2023

Anticipated Study Completion Date :

Oct 25, 2023

Outcome Measures

Primary Outcome Measures

Health-Related Quality of Life (HRQL), general [Monthly throughout 5 year study duration]
EQ-5D-5L

Secondary Outcome Measures

Health-Related Quality of Life (HRQL), oncology [Monthly throughout 5 year study duration]
QLQ-C30
Health-Related Quality of Life (HRQL), symptoms [Monthly throughout 5 year study duration]
PRO-CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vitaccess Ltd	Oxford		United Kingdom	OX1 1BY

Sponsors and Collaborators

Vitaccess Ltd
Melanoma UK
Royal Marsden NHS Foundation Trust

Investigators

Principal Investigator: Mark JW Larkin, PhD, Vitaccess Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mark Larkin, Director, Vitaccess Ltd

ClinicalTrials.gov Identifier:

NCT03379454

Other Study ID Numbers:

5100-01-2017

First Posted:

Dec 20, 2017

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Oct 6, 2021