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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01511913




Trial ID
NCT01511913
Ethics application status
Date submitted
15/11/2011
Date registered
18/01/2012
Date last updated
15/08/2018

Titles & IDs
Public title
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Scientific title
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
ENCEPP/SDPP/2723
Secondary ID [2] 0 0
CA184-143
Universal Trial Number (UTN)
Trial acronym
IMAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cutaneous Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non-Interventional

Ipilimumab treated cohort of 1000 patients - All patients identified and followed prospectively

Non-Ipilimumab treated cohort of 800 patients - 600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed


Other interventions: Non-Interventional
Non-Interventional

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
Timepoint [1] 0 0
Every 12 months up to 5 years
Primary outcome [2] 0 0
Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
Timepoint [2] 0 0
Every 12 months up to 5 years
Primary outcome [3] 0 0
Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
Timepoint [3] 0 0
Every 12 months up to 5 years
Primary outcome [4] 0 0
Patterns of disease monitoring as observed in a real-world setting - 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
Timepoint [4] 0 0
Every 12 months up to 5 years
Secondary outcome [1] 0 0
Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
Timepoint [1] 0 0
Every 12 months up to 5 years
Secondary outcome [2] 0 0
Resource utilization associated with advanced melanoma treatment - Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs
Timepoint [2] 0 0
Every 12 months up to 5 years
Secondary outcome [3] 0 0
Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
Timepoint [3] 0 0
Every 12 months up to 5 years

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Canberra
Recruitment hospital [2] 0 0
Local Institution - Corrimal
Recruitment hospital [3] 0 0
Local Institution - Lismore
Recruitment hospital [4] 0 0
Local Institution - Port Macquarie
Recruitment hospital [5] 0 0
Local Institution - Tamworth
Recruitment hospital [6] 0 0
Local Institution - Tweeds Head
Recruitment hospital [7] 0 0
Local Institution - Wagga Wagga
Recruitment hospital [8] 0 0
Local Institution - Waratah
Recruitment hospital [9] 0 0
Local Institution - Cairns
Recruitment hospital [10] 0 0
Local Institution - Douglas
Recruitment hospital [11] 0 0
Local Institution - Greenslopes
Recruitment hospital [12] 0 0
Local Institution - Adelaide
Recruitment hospital [13] 0 0
Local Institution - Bedford Park
Recruitment hospital [14] 0 0
Local Institution - Frankston
Recruitment hospital [15] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
02605 - Canberra
Recruitment postcode(s) [2] 0 0
02518 - Corrimal
Recruitment postcode(s) [3] 0 0
02480 - Lismore
Recruitment postcode(s) [4] 0 0
02444 - Port Macquarie
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02340 - Tamworth
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02485 - Tweeds Head
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2650 - Wagga Wagga
Recruitment postcode(s) [8] 0 0
02298 - Waratah
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
04810 - Douglas
Recruitment postcode(s) [11] 0 0
4120 - Greenslopes
Recruitment postcode(s) [12] 0 0
05000 - Adelaide
Recruitment postcode(s) [13] 0 0
05042 - Bedford Park
Recruitment postcode(s) [14] 0 0
03199 - Frankston
Recruitment postcode(s) [15] 0 0
03144 - Malvern
Recruitment outside Australia
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Caba
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Cordoba
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Linz
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Vienna
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Edegem
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Hasselt
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Birmingham
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Bristol
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Exeter
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Hull
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Poole
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01511913
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries