ClinicalTrials.gg
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
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 269 studies in Melanoma with a site in United Kingdom — 31 open to participants now, 74 under way, 24 of them phase 3. Melanoma · United Kingdom.

Enrollment
15th of 41
819 · median 400
Started
2017
with 16 others
Observational
41 of 269
9 open now
Registered
144th of 269
by date

Among the 269 studies in Melanoma with a site in United Kingdom, this one is the 15th largest by enrollment of the 41 observational ones that give a count, is one of 17 that started in 2017, is one of 41 observational ones, and was the 144th registered.

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

Browse Melanoma studies →

Open to participants now

31 of the 269 studies in Melanoma with a site in United Kingdom are open now. Recruiting first, the newest first:

26 more — sign in →

All 31 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 467 Melanoma studies recruiting now, 380 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Melanoma

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04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
819 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
06

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

07

Study locations

1 site
  • Vitaccess Ltd
    Oxford, OX1 1BY, United Kingdom
08

References and documents

Individual participant data

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2021, 49 months.

Of 59 industry-sponsored observational studies under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 80. This study's 49 months is above that.

Counting every sponsor, half of 236 studies reached it within 71 months; a quarter within 35 and three quarters within 248.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2017
First posted
Dec 20, 2017
StartActual
Oct 25, 2017
Primary completionActual
Dec 6, 2021
CompletionActual
Dec 6, 2021
Last update
Mar 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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