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A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma (IMAGE)

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ClinicalTrials.gov Identifier: NCT01511913
Recruitment Status : Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting.

Condition or disease Intervention/treatment
Advanced Cutaneous Melanoma Other: Non-Interventional

Detailed Description:
Time Perspective: this study does have a retrospective component involving a subset of patients.

Study Design
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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Actual Study Start Date : April 30, 2012
Estimated Primary Completion Date : May 11, 2020
Estimated Study Completion Date : November 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ipilimumab treated cohort of 1000 patients
All patients identified and followed prospectively
 Other: Non-Interventional
Non-Interventional
Non-Ipilimumab treated cohort of 800 patients
600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed
 Other: Non-Interventional
Non-Interventional


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting [ Time Frame: Every 12 months up to 5 years ]
  2. Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events [ Time Frame: Every 12 months up to 5 years ]
  3. Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab [ Time Frame: Every 12 months up to 5 years ]
  4. Patterns of disease monitoring as observed in a real-world setting [ Time Frame: Every 12 months up to 5 years ]
    To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination


Secondary Outcome Measures :
  1. Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma [ Time Frame: Every 12 months up to 5 years ]
  2. Resource utilization associated with advanced melanoma treatment [ Time Frame: Every 12 months up to 5 years ]
    Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs

  3. Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma [ Time Frame: Every 12 months up to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Diagnosis of unresectable or metastatic melanoma
  • Age of 18 years or older at time of entry into the study
  • Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent
  • Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment

Exclusion Criteria:

  • Current or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)
  • Current use of therapy to treat a primary cancer other than melanoma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511913


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site Investigator Inquiry form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01511913     History of Changes
Other Study ID Numbers: CA184-143
ENCEPP/SDPP/2723 ( Other Identifier: Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance )
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Keywords provided by Bristol-Myers Squibb:
Unresectable or metastatic cutaneous melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas