NCT03450876

Brief Summary

Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

February 15, 2018

Last Update Submit

September 9, 2020

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline up to 3 years

  • Multidimensional Fatigue Inventory (MFI)

    Baseline up to 3 years

  • Cancer Worry Scale (CWS)

    Baseline up to 3 years

  • 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)

    Baseline up to 3 years

  • +4 more secondary outcomes

Study Arms (4)

Healthy Control

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

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

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

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

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

24 to < 36 months post-ipilimumab treatmentHealthy Control≥ 36 to < 48 months post-ipilimumab treatment≥ 48 months post-ipilimumab treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient understanding of the Dutch language
  • Other anticancer treatment after ipilimumab or during study entry
  • Disease recurrence during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Amsterdam, 1066 CX, Netherlands

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 1, 2018

Study Start

December 15, 2016

Primary Completion

June 17, 2020

Study Completion

June 17, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Locations

NL(1)