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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01511913
Recruitment Status : Unknown
Verified December 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date November 15, 2011
First Posted Date January 19, 2012
Last Update Posted Date December 31, 2018
Actual Study Start Date April 30, 2012
Estimated Primary Completion Date May 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2012)
  • 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 ]
  • Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events [ Time Frame: Every 12 months up to 5 years ]
  • 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 ]
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 18, 2012)
  • 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 ]
  • 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
  • Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma [ Time Frame: Every 12 months up to 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Official Title A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
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.
Detailed Description Time Perspective: this study does have a retrospective component involving a subset of patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Advanced Cutaneous Melanoma
Intervention Other: Non-Interventional
Non-Interventional
Study Groups/Cohorts
  • Ipilimumab treated cohort of 1000 patients
    All patients identified and followed prospectively
    Intervention: Other: Non-Interventional
  • Non-Ipilimumab treated cohort of 800 patients
    600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed
    Intervention: Other: Non-Interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 18, 2012)
1800
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 28, 2020
Estimated Primary Completion Date May 11, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Greece,   Ireland,   Israel,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Brazil,   Mexico
 
Administrative Information
NCT Number NCT01511913
Other Study ID Numbers CA184-143
ENCEPP/SDPP/2723 ( Other Identifier: Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2018