The Impact of Melanoma and Drug Treatment in the Real World

NCT03379454 | Completed DMC

• 1 other identifier: 5100-01-2017
• Study Type: observational
• Target: 819
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life (HRQL), general

  EQ-5D-5L

  Monthly throughout 4 year study duration

Secondary Outcomes (2)

• Health-Related Quality of Life (HRQL), oncology

  Monthly throughout 4 year study duration

• Health-Related Quality of Life (HRQL), symptoms

  Monthly throughout 4 year study duration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Vitaccess Ltd: lead
• Melanoma UK: collaborator
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

Vitaccess Ltd

Oxford, OX1 1BY, United Kingdom

Location

Related Links

• Digital platform used to support the study
• Research portal via which anonymised data can be made available to approved researchers

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark JW Larkin, PhD

  Vitaccess Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 20, 2017
• Study Start: October 25, 2017
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)