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Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort |
| |
| 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 |
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| ≥ 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 |
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| ≥ 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline up to 3 years |
| Multidimensional Fatigue Inventory (MFI) |
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Inclusion Criteria-
Exclusion Criteria
Other protocol defined inclusion/exclusion criteria could apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Amsterdam | 1066 CX | Netherlands |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) |
| 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 | 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 | Baseline up to 3 years |
| Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M) | 51-item measurement of quality of life | Baseline up to 3 years |
| EuroQOL-5D (EQ-5D) survivors | Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors | 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 | 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 | Baseline up to 3 years |
| EORTC information module (EORTC QLQINFO25) | Information needs will be assessed with the EORTC information module (EORTC QLQINFO25) | Baseline up to 3 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |