MelanomaNCT03379454
The Impact of Melanoma and Drug Treatment in the Real World
An observational study of Melanoma, run by Vitaccess Ltd at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 819 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2017to 6 Dec 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQL), general
EQ-5D-5L
Measured: Monthly throughout 4 year study duration
Secondary outcomes (2)
Health-Related Quality of Life (HRQL), oncology
QLQ-C30
Measured: Monthly throughout 4 year study duration
Health-Related Quality of Life (HRQL), symptoms
PRO-CTCAE
Measured: Monthly throughout 4 year study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start25 Oct 2017
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 819 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vitaccess Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Melanoma UK, Royal Marsden NHS Foundation Trust
- Responsible party
- Principal investigator, Mark Larkin, Vitaccess Ltd
- Investigators
- Mark JW Larkin, PhD, Principal investigator, Vitaccess Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379454
- Sponsor's protocol ID
- 5100-01-2017
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2017
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated data research dashboards will be available via industry subscriptions or free academic access.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Melanoma and Drug Treatment in the Real World
- ClinicalTrials.gov ID
- NCT03379454
- Acronym / sponsor ID
- 5100-01-2017
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 819 participants (actual)
- Lead sponsor
- Vitaccess LtdIndustry (pharma, biotech, devices)
- Collaborators
- Melanoma UK, Royal Marsden NHS Foundation Trust
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-Related Quality of Life (HRQL), general
Time frame: Monthly throughout 4 year study duration
EQ-5D-5L
2 secondary outcomes
Health-Related Quality of Life (HRQL), oncology
Time frame: Monthly throughout 4 year study duration
Health-Related Quality of Life (HRQL), symptoms
Time frame: Monthly throughout 4 year study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Digital platform used to support the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Aggregated data research dashboards will be available via industry subscriptions or free academic access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark JW Larkin, PhD principal investigator
Vitaccess Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Vitaccess Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQL), general (time frame: Monthly throughout 4 year study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.