Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Ipilimumab treatment cohort of 1106 prospective participants -

Non-Ipilimumab treatment cohort of 305 prospective participants -

Retrospective cohort of 177 participants -

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
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
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
Sex
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
Completed
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 - Kurralta Park
Recruitment hospital [15] 0 0
Local Institution - Frankston
Recruitment hospital [16] 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
Recruitment postcode(s) [5] 0 0
02340 - Tamworth
Recruitment postcode(s) [6] 0 0
02485 - Tweeds Head
Recruitment postcode(s) [7] 0 0
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
5037 - Kurralta Park
Recruitment postcode(s) [15] 0 0
03199 - Frankston
Recruitment postcode(s) [16] 0 0
03144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Caba
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Rosario- Santa Fe
Country [19] 0 0
Argentina
State/province [19] 0 0
Tucuman
Country [20] 0 0
Austria
State/province [20] 0 0
Feldkirch
Country [21] 0 0
Austria
State/province [21] 0 0
Graz
Country [22] 0 0
Austria
State/province [22] 0 0
Linz
Country [23] 0 0
Austria
State/province [23] 0 0
Salzburg
Country [24] 0 0
Austria
State/province [24] 0 0
St Poelten
Country [25] 0 0
Austria
State/province [25] 0 0
Vienna
Country [26] 0 0
Belgium
State/province [26] 0 0
Brasschaat
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Edegem
Country [29] 0 0
Belgium
State/province [29] 0 0
Haint Saint Paul
Country [30] 0 0
Belgium
State/province [30] 0 0
Hasselt
Country [31] 0 0
Belgium
State/province [31] 0 0
Kortrijk
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Canada
State/province [33] 0 0
New Brunswick
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Saskatchewan
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Canada
State/province [37] 0 0
Québec
Country [38] 0 0
France
State/province [38] 0 0
Bayonne
Country [39] 0 0
France
State/province [39] 0 0
Besancon
Country [40] 0 0
France
State/province [40] 0 0
Boulogne sur Mer
Country [41] 0 0
France
State/province [41] 0 0
Boulogne
Country [42] 0 0
France
State/province [42] 0 0
Brest Cedex
Country [43] 0 0
France
State/province [43] 0 0
Clermont Ferrand Cédex 1
Country [44] 0 0
France
State/province [44] 0 0
Dijon
Country [45] 0 0
France
State/province [45] 0 0
Grenoble Cédex
Country [46] 0 0
France
State/province [46] 0 0
Lille Cedex
Country [47] 0 0
France
State/province [47] 0 0
Limoges Cedex
Country [48] 0 0
France
State/province [48] 0 0
Montauban
Country [49] 0 0
France
State/province [49] 0 0
Mougins
Country [50] 0 0
France
State/province [50] 0 0
Nouvelle Caledonie
Country [51] 0 0
France
State/province [51] 0 0
Paris Cedex 10
Country [52] 0 0
France
State/province [52] 0 0
Pierre Bénite
Country [53] 0 0
France
State/province [53] 0 0
Quimper Cedex
Country [54] 0 0
France
State/province [54] 0 0
Quimper
Country [55] 0 0
France
State/province [55] 0 0
Soissons cedex
Country [56] 0 0
France
State/province [56] 0 0
Strasbourg Cedex
Country [57] 0 0
France
State/province [57] 0 0
Vandoeuvre Les Nancy
Country [58] 0 0
Germany
State/province [58] 0 0
Augsburg
Country [59] 0 0
Germany
State/province [59] 0 0
Bochum
Country [60] 0 0
Germany
State/province [60] 0 0
Buxtehude
Country [61] 0 0
Germany
State/province [61] 0 0
Chemnitz
Country [62] 0 0
Germany
State/province [62] 0 0
Darmstadt
Country [63] 0 0
Germany
State/province [63] 0 0
Dessau-Roblau
Country [64] 0 0
Germany
State/province [64] 0 0
Dortmund
Country [65] 0 0
Germany
State/province [65] 0 0
Dresden
Country [66] 0 0
Germany
State/province [66] 0 0
Düsseldorf
Country [67] 0 0
Germany
State/province [67] 0 0
Frankfurt
Country [68] 0 0
Germany
State/province [68] 0 0
Gera
Country [69] 0 0
Germany
State/province [69] 0 0
Halle/Saale
Country [70] 0 0
Germany
State/province [70] 0 0
Hamburg
Country [71] 0 0
Germany
State/province [71] 0 0
Hannover
Country [72] 0 0
Germany
State/province [72] 0 0
Jena
Country [73] 0 0
Germany
State/province [73] 0 0
Koblenz
Country [74] 0 0
Germany
State/province [74] 0 0
Lüdenscheid
Country [75] 0 0
Germany
State/province [75] 0 0
Magdeburg
Country [76] 0 0
Germany
State/province [76] 0 0
Mainz
Country [77] 0 0
Germany
State/province [77] 0 0
Mannheim
Country [78] 0 0
Germany
State/province [78] 0 0
Marburg
Country [79] 0 0
Germany
State/province [79] 0 0
Münster
Country [80] 0 0
Germany
State/province [80] 0 0
Plauen
Country [81] 0 0
Germany
State/province [81] 0 0
Quedlinburg
Country [82] 0 0
Germany
State/province [82] 0 0
Recklinghausen
Country [83] 0 0
Germany
State/province [83] 0 0
Rostock
Country [84] 0 0
Germany
State/province [84] 0 0
Schwäbisch Hall
Country [85] 0 0
Germany
State/province [85] 0 0
Stuttgart
Country [86] 0 0
Germany
State/province [86] 0 0
Tübingen
Country [87] 0 0
Germany
State/province [87] 0 0
Würzburg
Country [88] 0 0
Greece
State/province [88] 0 0
Athens
Country [89] 0 0
Greece
State/province [89] 0 0
Crete
Country [90] 0 0
Greece
State/province [90] 0 0
Thessaloniki
Country [91] 0 0
Greece
State/province [91] 0 0
Alexandroupolis
Country [92] 0 0
Greece
State/province [92] 0 0
Mezourlo
Country [93] 0 0
Greece
State/province [93] 0 0
Neo Faliro
Country [94] 0 0
Ireland
State/province [94] 0 0
Cork
Country [95] 0 0
Ireland
State/province [95] 0 0
Dublin
Country [96] 0 0
Ireland
State/province [96] 0 0
Galway
Country [97] 0 0
Ireland
State/province [97] 0 0
Tullamore
Country [98] 0 0
Israel
State/province [98] 0 0
Haifa
Country [99] 0 0
Israel
State/province [99] 0 0
Tel Aviv
Country [100] 0 0
Israel
State/province [100] 0 0
Tel Hashomer
Country [101] 0 0
Poland
State/province [101] 0 0
Bydgoszcz
Country [102] 0 0
Poland
State/province [102] 0 0
Warszawa
Country [103] 0 0
Poland
State/province [103] 0 0
Wroclaw
Country [104] 0 0
Poland
State/province [104] 0 0
Lódz
Country [105] 0 0
Spain
State/province [105] 0 0
Barcelona
Country [106] 0 0
Spain
State/province [106] 0 0
Donostia
Country [107] 0 0
Spain
State/province [107] 0 0
Las Palmas de Gran Canaria
Country [108] 0 0
Spain
State/province [108] 0 0
Madrid
Country [109] 0 0
Spain
State/province [109] 0 0
Palma de Mallorca
Country [110] 0 0
Spain
State/province [110] 0 0
Palma
Country [111] 0 0
Spain
State/province [111] 0 0
Pamplona
Country [112] 0 0
Spain
State/province [112] 0 0
Santa Cruz de Tenerife
Country [113] 0 0
Spain
State/province [113] 0 0
Santander
Country [114] 0 0
Spain
State/province [114] 0 0
Santiago De Compostela; A Coruña
Country [115] 0 0
Spain
State/province [115] 0 0
Sevilla
Country [116] 0 0
Spain
State/province [116] 0 0
Sta Cruz de Tenerife
Country [117] 0 0
Spain
State/province [117] 0 0
Terrassa
Country [118] 0 0
Spain
State/province [118] 0 0
Valladolid
Country [119] 0 0
Spain
State/province [119] 0 0
Zaragoza
Country [120] 0 0
Switzerland
State/province [120] 0 0
Baden
Country [121] 0 0
Switzerland
State/province [121] 0 0
Lugano
Country [122] 0 0
Switzerland
State/province [122] 0 0
Zurich
Country [123] 0 0
Switzerland
State/province [123] 0 0
Zürich
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Denbigshire
Country [125] 0 0
United Kingdom
State/province [125] 0 0
England
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Essex
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Ireland
Country [128] 0 0
United Kingdom
State/province [128] 0 0
South Glamorgan
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Birmingham
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Bristol
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Exeter
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Hull
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Leeds
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Lincoln
Country [135] 0 0
United Kingdom
State/province [135] 0 0
London
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Oxfordshire
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Plymouth
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Poole
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Preston
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Staffordshire
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Taunton, Somerset
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Truro, Cornwall
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Wirral
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Wolverhampton
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Yeovil, Somerset

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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