ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CA184-143
Previous Study | Return to List | Next Study

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 : Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 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

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


  Hide Study Locations
Locations
United States, Arizona
Local Institution
Gilbert, Arizona, United States, 85234
United States, Arkansas
Local Institution
Hot Springs, Arkansas, United States, 71913
United States, California
Local Institution
Encinitas, California, United States, 92024
Local Institution
La Jolla, California, United States, 92093
Local Institution
Long Beach, California, United States, 90813
Local Institution
Los Angeles, California, United States, 90025
United States, Colorado
Local Institution
Denver, Colorado, United States, 80218
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States, 20010
United States, Florida
Local Institution
Lakeland, Florida, United States, 33085
Local Institution
Miami Beach, Florida, United States, 33140
Local Institution
Orange Park, Florida, United States, 32073
United States, Illinois
Local Institution
Chicago, Illinois, United States, 60612
Local Institution
Niles, Illinois, United States, 60714
United States, Michigan
Local Institution
Detroit, Michigan, United States, 48201
United States, Mississippi
Local Institution
Hattiesburg, Mississippi, United States, 39401
United States, Nebraska
Local Institution
Lincoln, Nebraska, United States, 18015
United States, New Jersey
Local Institution
Morristown, New Jersey, United States, 07960
United States, Ohio
Local Institution
Canton, Ohio, United States, 44178
Local Institution
Columbus, Ohio, United States, 43219
Local Institution
Middletown, Ohio, United States, 45042
United States, Oregon
Local Institution
Portland, Oregon, United States, 97213
United States, Tennessee
Local Institution
Knoxville, Tennessee, United States, 37920
United States, Washington
Local Institution
Everett, Washington, United States, 98201
Argentina
Local Institution
Caba, Argentina, C1417DNT
Local Institution
Caba, Argentina, C1426ANZ
Local Institution
Cordoba, Argentina, X5006HBF
Local Institution
Rosario- Santa Fe, Argentina, S2000KZE
Local Institution
Tucuman, Argentina, T4000GTB
Australia, Australian Capital Territory
Local Institution
Canberra, Australian Capital Territory, Australia, 02605
Australia, New South Wales
Local Institution
Corrimal, New South Wales, Australia, 02518
Local Institution
Lismore, New South Wales, Australia, 02480
Local Institution
Port Macquarie, New South Wales, Australia, 02444
Local Institution
Tamworth, New South Wales, Australia, 02340
Local Institution
Tweeds Head, New South Wales, Australia, 02485
Local Institution
Wagga Wagga, New South Wales, Australia, 2650
Local Institution
Waratah, New South Wales, Australia, 02298
Australia, Queensland
Local Institution
Cairns, Queensland, Australia, 4870
Local Institution
Douglas, Queensland, Australia, 04810
Local Institution
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 05000
Local Institution
Bedford Park, South Australia, Australia, 05042
Australia, Victoria
Local Institution
Frankston, Victoria, Australia, 03199
Local Institution
Malvern, Victoria, Australia, 03144
Austria
Local Institution
Graz, Austria, A-8036
Local Institution
Linz, Austria, A-4020
Local Institution
Salzburg, Austria, A-5020
Local Institution
St Poelten, Austria, A-3100
Local Institution
Vienna, Austria, A-1090
Belgium
Local Institution
Brasschaat, Belgium, 2930
Local Institution
Brussels, Belgium, 1200
Local Institution
Edegem, Belgium, 2650
Local Institution
Haint Saint Paul, Belgium, 7100
Local Institution
Hasselt, Belgium, 3500
Local Institution
Kortrijk, Belgium, 8500
Local Institution
Leuven, Belgium, 3000
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Local Institution
London, Ontario, Canada, N6C 6B5
Local Institution
Mississauga, Ontario, Canada, L5M 2N1
Local Institution
Windsor, Ontario, Canada, N8W 2X3
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Local Institution
Québec, Canada, G1R 2J6
France
Local Institution
Bayonne, France, 64100
Local Institution
Besancon, France, 25000
Local Institution
Boulogne sur Mer, France, 62200
Local Institution
Boulogne, France, 92104
Local Institution
Brest Cedex, France, 29609
Local Institution
Clermont Ferrand Cédex 1, France, 63003
Local Institution
Dijon, France, 21079
Local Institution
Grenoble Cédex, France, 38043
Local Institution
Lille Cedex, France, 59037
Local Institution
Limoges Cedex, France, 87042
Local Institution
Montauban, France, 82000
Local Institution
Mougins, France, 06250
Local Institution
Nouvelle Caledonie, France, 98849
Local Institution
Paris Cedex 10, France, 75475
Local Institution
Pierre Bénite, France, 69495
Local Institution
Quimper, France, 29107
Local Institution
Soissons cedex, France, 02209
Local Institution
Strasbourg Cedex, France, 67065
Local Institution
Vandoeuvre Les Nancy, France, 54500
Germany
Local Institution
Augsburg, Germany, 86156
Local Institution
Bochum, Germany, 44791
Local Institution
Buxtehude, Germany, 21614
Local Institution
Chemnitz, Germany, 09117
Local Institution
Darmstadt, Germany, 64297
Local Institution
Dessau-Roblau, Germany, 06847
Local Institution
Dortmund, Germany, 44137
Local Institution
Dresden, Germany, 01307
Local Institution
Düsseldorf, Germany, 40225
Local Institution
Frankfurt, Germany, 60590
Local Institution
Gera, Germany, 07548
Local Institution
Halle/Saale, Germany, 06120
Local Institution
Hamburg, Germany, 20099
Local Institution
Hamburg, Germany, 20246
Local Institution
Hamburg, Germany, 20253
Local Institution
Hannover, Germany, 30625
Local Institution
Jena, Germany, 07743
Local Institution
Koblenz, Germany, 56068
Local Institution
Lüdenscheid, Germany, 58515
Local Institution
Magdeburg, Germany, 39120
Local Institution
Mainz, Germany, 55131
Local Institution
Mannheim, Germany, 68167
Local Institution
Marburg, Germany, 35043
Local Institution
Münster, Germany, 48149
Local Institution
Plauen, Germany, 08529
Local Institution
Quedlinburg, Germany, 06484
Local Institution
Recklinghausen, Germany, 45657
Local Institution
Rostock, Germany, 18055
Local Institution
Schwäbisch Hall, Germany, 74523
Local Institution
Stuttgart, Germany, 70374
Local Institution
Tübingen, Germany, 72076
Local Institution
Würzburg, Germany, 97080
Greece
Local Institution
Cholargos, Athens, Greece, 15562
Local institution
Goudi, Athens, Greece, 11527
Local Institution
Neo Faliro, Athens, Greece, 18547
Local Institution
Heraklion, Crete, Greece, 71100
Local Institution
Neas Efkarpia, Thessaloniki, Greece, 56429
Local Institutio
Alexandroupolis, Greece, 68100
Local Institution
Athens, Greece, 11528
Local Institution
Athens, Greece, 15233
Local Institution
Mezourlo, Greece, 41334
Ireland
Local Institution
Cork, Ireland
Local Institution
Dublin, Ireland
Local Institution
Galway, Ireland
Local Institution
Tullamore, Ireland
Israel
Local Institution
Haifa, Israel, 31096
Local Institution
Tel Aviv, Israel, 64239
Local Institution
Tel Hashomer, Israel, 52621
Poland
Local Institution
Bydgoszcz, Poland, 85-796
Local Institution
Warszawa, Poland, 02-781
Local Institution
Wrocław, Poland, 51-124
Local Institution
Łódź, Poland, 93-510
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
Donostia, Spain, 20014
Local Institution
Las Palmas de Gran Canaria, Spain, 35016
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28033
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28041
Local Institution
Palma, Spain, 07198
Local Institution
Pamplona, Spain, 31008
Local Institution
Santa Cruz de Tenerife, Spain, 38010
Local Institution
Santander, Spain, 39008
Local Institution
Santiago De Compostela; A Coruña, Spain, 15706
Local Institution
Sevilla, Spain, 41013
Local Institution
Sta Cruz de Tenerife, Spain, 35320
Local Institution
Terrassa, Spain, 08027
Local Institution
Valladolid, Spain, 47012
Local Institution
Zaragoza, Spain, 50009
Switzerland
Local Institution
Baden, Switzerland, CH-5404
Local Institution
Lugano, Switzerland, CH-6900
Local Institution
Zürich, Switzerland, CH-8091
United Kingdom
Local Institution
Rhyl, Denbigshire, United Kingdom, LL18 5UJ
Local Institution
London, England, United Kingdom, NW3 2QG
Local Institution
Chelmsford, Essex, Essex, United Kingdom, CM1 7ET
Local Institution
Southend, Essex, United Kingdom, SS0 0RY
Local Institution
Belfast, Ireland, United Kingdom, BT9 7AB
Local Institution
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
Local Institution
Birmingham, United Kingdom, B15 2TH
Local Institution
Bristol, United Kingdom, BS2 8ED
Local Institution
Exeter, United Kingdom, EX2 5DW
Local Institution
Hull, United Kingdom, HU16 5JQ
Local Institution
Leeds, United Kingdom, LS9 7TF
Local Institution
Lincoln, United Kingdom, LN2 5QY
Local Institution
London, United Kingdom, SE1 9RT
Local Institution
London, United Kingdom, SW3 6JJ
Local Institution
Oxfordshire, United Kingdom, OX3 7LE
Local Institution
Plymouth, United Kingdom, PL6 8DH
Local Institution
Poole, United Kingdom, BH15 2JB
Local Institution
Preston, United Kingdom, PR2 9HT
Local Institution
Staffordshire, United Kingdom, ST46QG
Local Institution
Taunton, Somerset, United Kingdom, TA1 5DA
Local Institution
Truro, Cornwall, United Kingdom, TR1 3LJ
Local Institution
Wirral, United Kingdom, CH63 4JY
Local Institution
Wolverhampton, United Kingdom, WS13 6NH
Local Institution
Yeovil, Somerset, United Kingdom, BA21 4AT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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: October 17, 2018
Last Verified: October 2018

Keywords provided by Bristol-Myers Squibb:
Unresectable or metastatic cutaneous melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas