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CompletedNCT03379454Updated Mar 21, 2023

The Impact of Melanoma and Drug Treatment in the Real World

An observational study in Melanoma, sponsored by Vitaccess Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Vitaccess Ltd · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
819
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Melanoma

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • no specific exclusion criteria
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
819 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
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What researchers measure

Primary outcomes

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

    EQ-5D-5L

    Time frame: Monthly throughout 4 year study duration

Secondary outcomes

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

    QLQ-C30

    Time frame: Monthly throughout 4 year study duration

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

    PRO-CTCAE

    Time frame: Monthly throughout 4 year study duration

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Study locations

1 site
  • Vitaccess Ltd
    Oxford, OX1 1BY, United Kingdom
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References and documents

Individual participant data

Plan to share: No — Aggregated data research dashboards will be available via industry subscriptions or free academic access.

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Registry details

Key details

Study ID
NCT03379454
Lead sponsor
Vitaccess Ltd
Collaborators
Melanoma UK, Royal Marsden NHS Foundation Trust
Responsible party
Mark Larkin (Director, Vitaccess Ltd) — Principal investigator
First posted
Dec 20, 2017
Start date
Oct 25, 2017
Primary completion
Dec 6, 2021
Completion
Dec 6, 2021
Last update
Mar 21, 2023

Study contacts

Mark JW Larkin, PhD
principal investigator · Vitaccess Ltd

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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