The Impact of Melanoma and Drug Treatment in the Real World

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03379454

Enrollment

819

Registered

2017-12-20

Start date

2017-10-25

Completion date

2021-12-06

Last updated

2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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.

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results