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Long Term Quality of Life in Melanoma Patients in Netherlands

NCT ID: NCT03450876

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-15

Study Completion Date

2020-06-17

Brief Summary

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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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Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Control

Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort

Non-Interventional

Intervention Type 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

Non-Interventional

Intervention Type 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

Non-Interventional

Intervention Type 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

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Insufficient understanding of the Dutch language
* Other anticancer treatment after ipilimumab or during study entry
* Disease recurrence during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CA209-483

Identifier Type: -

Identifier Source: org_study_id

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