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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01511913
Registration number
NCT01511913
Ethics application status
Date submitted
15/11/2011
Date registered
19/01/2012
Date last updated
28/12/2021
Titles & IDs
Public title
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
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Scientific title
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
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Secondary ID [1]
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ENCEPP/SDPP/2723
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Secondary ID [2]
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CA184-143
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Universal Trial Number (UTN)
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Trial acronym
IMAGE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cutaneous Melanoma
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0
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Ipilimumab treatment cohort of 1106 prospective participants -
Non-Ipilimumab treatment cohort of 305 prospective participants -
Retrospective cohort of 177 participants -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
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Assessment method [1]
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Timepoint [1]
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Every 12 months up to 5 years
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Primary outcome [2]
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Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
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Assessment method [2]
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0
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Timepoint [2]
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Every 12 months up to 5 years
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Primary outcome [3]
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Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
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Assessment method [3]
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0
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Timepoint [3]
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Every 12 months up to 5 years
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Primary outcome [4]
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Patterns of disease monitoring as observed in a real-world setting
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Assessment method [4]
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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
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Timepoint [4]
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Every 12 months up to 5 years
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Secondary outcome [1]
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Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
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Assessment method [1]
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0
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Timepoint [1]
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Every 12 months up to 5 years
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Secondary outcome [2]
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Resource utilization associated with advanced melanoma treatment
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Assessment method [2]
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Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs
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Timepoint [2]
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Every 12 months up to 5 years
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Secondary outcome [3]
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Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
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Assessment method [3]
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0
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Timepoint [3]
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Every 12 months up to 5 years
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/12/2019
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Sample size
Target
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Accrual to date
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Final
1411
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - Canberra
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Local Institution - Bedford Park
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Local Institution - Kurralta Park
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Local Institution - Frankston
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Recruitment hospital [16]
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Local Institution - Malvern
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Recruitment postcode(s) [1]
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02605 - Canberra
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Recruitment postcode(s) [2]
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02518 - Corrimal
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Recruitment postcode(s) [3]
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02480 - Lismore
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Recruitment postcode(s) [4]
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02444 - Port Macquarie
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Recruitment postcode(s) [5]
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02340 - Tamworth
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Recruitment postcode(s) [6]
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02485 - Tweeds Head
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Recruitment postcode(s) [7]
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2650 - Wagga Wagga
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Recruitment postcode(s) [8]
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02298 - Waratah
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Recruitment postcode(s) [9]
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4870 - Cairns
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Recruitment postcode(s) [10]
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04810 - Douglas
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Recruitment postcode(s) [11]
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4120 - Greenslopes
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05000 - Adelaide
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05042 - Bedford Park
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Recruitment postcode(s) [14]
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5037 - Kurralta Park
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Recruitment postcode(s) [15]
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03199 - Frankston
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Recruitment postcode(s) [16]
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03144 - Malvern
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Recruitment outside Australia
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Cork
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Zürich
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Denbigshire
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England
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Essex
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Ireland
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South Glamorgan
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Birmingham
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Bristol
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Exeter
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Hull
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Leeds
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Lincoln
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London
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Oxfordshire
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Plymouth
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Poole
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Preston
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Staffordshire
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Taunton, Somerset
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Wirral
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Wolverhampton
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Yeovil, Somerset
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT01511913
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Trial related presentations / publications
Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y. Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Dalle S, Mortier L, Corrie P, Lotem M, Board R, Ar...
[
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Journal
Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer...
[
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]
Results not provided in
https://clinicaltrials.gov/study/NCT01511913
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