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NCT Number: NCT03379454

The Impact of Melanoma and Drug Treatment in the Real World

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitaccess Ltd

Oxford, OX1 1BY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Health-Related Quality of Life (HRQL), general

    Time frame: Monthly throughout 4 year study duration

    EQ-5D-5L

Secondary outcomes

  1. Health-Related Quality of Life (HRQL), oncology

    Time frame: Monthly throughout 4 year study duration

    QLQ-C30

  2. Health-Related Quality of Life (HRQL), symptoms

    Time frame: Monthly throughout 4 year study duration

    PRO-CTCAE

Sponsors and collaborators

Lead sponsor

Vitaccess Ltd

Industry

Collaborators

  • Melanoma UK
  • Royal Marsden NHS Foundation Trust

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2017
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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