MelanomaNCT03450876
Long Term Quality of Life in Melanoma Patients in Netherlands
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in Netherlands.
Trial summary
Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Non-Interventional
- Type of treatment
- Injection or infusion
- How many people
- 89 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2016to 17 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with advanced melanoma who survived at least 2 years and were treated with ipilimumab between 2011 and 2015 in one of the specified melanoma centers in the Netherlands.
Who may be able to join
- Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration)
- Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
Who cannot join
- Insufficient understanding of the Dutch language
- Other anticancer treatment after ipilimumab or during study entry
- Disease recurrence during the study
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Cohort Study of Late Physical Psychological and Social Effects in Patients Treated With Ipilimumab for Advanced Melanoma
Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.
- Conditions
- Melanoma
- Being tested
- Non-Interventional
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort Receives: Other: Non-Interventional | |
| 24 to < 36 months post-ipilimumab treatment | 24 to 36 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2014 in one of the 14 melanoma centers in the Netherlands Receives: Other: Non-Interventional | |
| ≥ 36 to < 48 months post-ipilimumab treatment | 36 to 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2013 in one of the 14 melanoma centers in the Netherlands Receives: Other: Non-Interventional | |
| ≥ 48 months post-ipilimumab treatment | Greater than 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab between 2011 and 2012 in one of the 14 melanoma centers in the Netherlands Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)
EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
Measured: Baseline up to 3 years
Secondary outcomes (9)
Hospital Anxiety and Depression Scale (HADS)
14-item questionnaire assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score
Measured: Baseline up to 3 years
Multidimensional Fatigue Inventory (MFI)
Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI)
Measured: Baseline up to 3 years
Cancer Worry Scale (CWS)
8-item questionnaire will be used to assess the prevalence of cancer-specific distress in melanoma survivors and in healthy controls
Measured: Baseline up to 3 years
European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health
Sexual health will be assessed with the European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health
Measured: Baseline up to 3 years
Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)
51-item measurement of quality of life
Measured: Baseline up to 3 years
EuroQOL-5D (EQ-5D) survivors
Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors
Measured: Baseline up to 3 years
Impact of Cancer Questionnaire (IOCv2)
81 items that present statements regarding specific impacts of cancer to which respondents indicate their level of agreement from 1 (strongly disagree) to 5 (strongly agree). Seventy items apply to all survivors, 3 to currently employed respondents, 4 to respondents not currently partnered, and 4 to currently partnered respondents
Measured: Baseline up to 3 years
Work Ability Index questionnaire (WAI)
13-item questionnaire developed to obtain survivors' experiences with return to work and work performance
Measured: Baseline up to 3 years
EORTC information module (EORTC QLQINFO25)
Information needs will be assessed with the EORTC information module (EORTC QLQINFO25)
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start15 Dec 2016
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450876
- Sponsor's protocol ID
- CA209-483
- Status last verified
- Sep 2020
- First submitted
- 15 Feb 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study of Late Physical Psychological and Social Effects in Patients Treated With Ipilimumab for Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03450876
- Acronym / sponsor ID
- CA209-483
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 1 Mar 2018 (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.
Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: Non-InterventionalIndividuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort |
| 24 to < 36 months post-ipilimumab treatment | – | Other: Non-Interventional24 to 36 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2014 in one of the 14 melanoma centers in the Netherlands |
| ≥ 36 to < 48 months post-ipilimumab treatment | – | Other: Non-Interventional36 to 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2013 in one of the 14 melanoma centers in the Netherlands |
| ≥ 48 months post-ipilimumab treatment | – | Other: Non-InterventionalGreater than 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab between 2011 and 2012 in one of the 14 melanoma centers in the Netherlands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced melanoma who survived at least 2 years and were treated with ipilimumab between 2011 and 2015 in one of the specified melanoma centers in the Netherlands.
Key inclusion criteria (2 listed)
- Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration)
- Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
Key exclusion criteria (4 listed)
- Insufficient understanding of the Dutch language
- Other anticancer treatment after ipilimumab or during study entry
- Disease recurrence during the study
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | 24 to < 36 months post-ipilimumab treatment, Healthy Control, ≥ 36 to < 48 months post-ipilimumab treatment, ≥ 48 months post-ipilimumab treatment |
Primary outcome
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)
Time frame: Baseline up to 3 years
EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
9 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline up to 3 years
Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline up to 3 years
Cancer Worry Scale (CWS)
Time frame: Baseline up to 3 years
European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health
Time frame: Baseline up to 3 years
Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)
Time frame: Baseline up to 3 years
EuroQOL-5D (EQ-5D) survivors
Time frame: Baseline up to 3 years
Impact of Cancer Questionnaire (IOCv2)
Time frame: Baseline up to 3 years
Work Ability Index questionnaire (WAI)
Time frame: Baseline up to 3 years
EORTC information module (EORTC QLQINFO25)
Time frame: Baseline up to 3 years
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 11 Sep 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Bristol-Myers Squibb at 1 site in Netherlands.
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 2 inclusion and 4 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 11 Sep 2020. 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 Netherlands. 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?
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30) (time frame: Baseline up to 3 years). 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 11 Sep 2020.