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Trial record 1 of 1 for:    CA184-143
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A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma (IMAGE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01511913
First received: November 15, 2011
Last updated: August 31, 2017
Last verified: August 2017
  Purpose
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 Intervention
Advanced Cutaneous Melanoma Other: Non-Interventional

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1800
Actual Study Start Date: April 30, 2012
Estimated Study Completion Date: March 30, 2020
Estimated Primary Completion Date: March 29, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:
Time Perspective: this study does have a retrospective component involving a subset of patients.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511913

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

  Hide Study Locations
Locations
United States, Arizona
Local Institution Active, not recruiting
Chandler, Arizona, United States, 85224
Local Institution Completed
Gilbert, Arizona, United States, 85234
United States, Arkansas
Local Institution Completed
Hot Springs, Arkansas, United States, 71913
United States, California
Local Institution Completed
Encinitas, California, United States, 92024
Local Institution Active, not recruiting
La Jolla, California, United States, 92037
Local Institution Completed
La Jolla, California, United States, 92093
Local Institution Active, not recruiting
Long Beach, California, United States, 90813
Local Institution Active, not recruiting
Los Angeles, California, United States, 90025
United States, Colorado
Local Institution Active, not recruiting
Denver, Colorado, United States, 80218
United States, District of Columbia
Local Institution Active, not recruiting
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Local Institution Active, not recruiting
Jacksonville, Florida, United States, 32256
Local Institution Active, not recruiting
Lakeland, Florida, United States, 33085
Local Institution Completed
Miami Beach, Florida, United States, 33140
Local Institution Completed
Orange Park, Florida, United States, 32073
United States, Illinois
Local Institution Completed
Chicago, Illinois, United States, 60612
Local Institution Completed
Niles, Illinois, United States, 60714
United States, Kansas
Local Institution Active, not recruiting
Wichita, Kansas, United States, 67214
United States, Michigan
Local Institution Completed
Detroit, Michigan, United States, 48201
United States, Mississippi
Local Institution Active, not recruiting
Hattiesburg, Mississippi, United States, 39401
United States, Nebraska
Local Institution Completed
Lincoln, Nebraska, United States, 18015
United States, Nevada
Local Institution Active, not recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Local Institution Active, not recruiting
Morristown, New Jersey, United States, 07960
United States, North Carolina
Local Institution Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Local Institution Active, not recruiting
Canton, Ohio, United States, 44178
Local Institution Completed
Columbus, Ohio, United States, 43219
Local Institution Completed
Middletown, Ohio, United States, 45042
United States, Oregon
Local Institution Completed
Portland, Oregon, United States, 97213
United States, Pennsylvania
Local Institution Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
Local Institution Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Local Institution Active, not recruiting
Knoxville, Tennessee, United States, 37920
United States, Washington
Local Institution Completed
Everett, Washington, United States, 98201
Argentina
Local Institution Active, not recruiting
Caba, Argentina, C1417DNT
Local Institution Completed
Caba, Argentina, C1426ANZ
Local Institution Completed
Cordoba, Argentina, X5006HBF
Local Institution Completed
Rosario- Santa Fe, Argentina, S2000KZE
Local Institution Active, not recruiting
Tucuman, Argentina, T4000GTB
Australia, Australian Capital Territory
Local Institution Completed
Canberra, Australian Capital Territory, Australia, 02605
Australia, New South Wales
Local Institution Completed
Corrimal, New South Wales, Australia, 02518
Local Institution Active, not recruiting
Lismore, New South Wales, Australia, 02480
Local Institution Active, not recruiting
Port Macquarie, New South Wales, Australia, 02444
Local Institution Active, not recruiting
Tamworth, New South Wales, Australia, 02340
Local Institution Active, not recruiting
Tweeds Head, New South Wales, Australia, 02485
Local Institution Active, not recruiting
Wagga Wagga, New South Wales, Australia, 2650
Local Institution Completed
Waratah, New South Wales, Australia, 02298
Australia, Queensland
Local Institution Active, not recruiting
Cairns, Queensland, Australia, 4870
Local Institution Active, not recruiting
Douglas, Queensland, Australia, 04810
Local Institution Active, not recruiting
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Local Institution Active, not recruiting
Adelaide, South Australia, Australia, 05000
Local Institution Completed
Bedford Park, South Australia, Australia, 05042
Australia, Victoria
Local Institution Completed
Frankston, Victoria, Australia, 03199
Local Institution Active, not recruiting
Malvern, Victoria, Australia, 03144
Austria
Local Institution Active, not recruiting
Graz, Austria, A-8036
Local Institution Active, not recruiting
Linz, Austria, A-4020
Local Institution Active, not recruiting
Salzburg, Austria, A-5020
Local Institution Completed
St Poelten, Austria, A-3100
Local Institution Completed
Vienna, Austria, A-1090
Belgium
Local Institution Completed
Brasschaat, Belgium, 2930
Local Institution Active, not recruiting
Brugge, Belgium, 8000
Local Institution Completed
Brussels, Belgium, 1200
Local Institution Completed
Edegem, Belgium, 2650
Local Institution Completed
Haint St. Paul, Belgium, 7100
Local Institution Active, not recruiting
Hasselt, Belgium, 3500
Local Institution Active, not recruiting
Kortrijk, Belgium, 8500
Local Institution Completed
Leuven, Belgium, 3000
Canada, New Brunswick
Local Institution Active, not recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Local Institution Active, not recruiting
London, Ontario, Canada, N6C 6B5
Local Institution Active, not recruiting
Mississauga, Ontario, Canada, L5M 2N1
Local Institution Completed
Windsor, Ontario, Canada, N8W 2X3
Canada, Saskatchewan
Local Institution Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Local Institution Completed
Québec, Canada, G1R 2J6
France
Local Institution Recruiting
Bayonne, France, 64100
Contact: Site 1606         
Local Institution Completed
Besancon, France, 25000
Local Institution Recruiting
Boulogne sur Mer, France, 62200
Contact: Site 1616         
Local Institution Completed
Boulogne, France, 92104
Local Institution Recruiting
Brest Cedex, France, 29609
Contact: Site 1607         
Local Institution Recruiting
Clermont Ferrand Cédex 1, France, 63003
Contact: Site 1622         
Local Institution Completed
Dijon, France, 21079
Local Institution Recruiting
Grenoble Cédex, France, 38043
Contact: Site 1624         
Local Institution Recruiting
Lille Cedex, France, 59037
Contact: Site 1621         
Local Institution Completed
Limoges Cedex, France, 87042
Local Institution Recruiting
Montauban, France, 82000
Contact: Site 1601         
Local Institution Completed
Mougins, France, 06250
Local Institution Completed
Nouvelle caledonie, France, 98849
Local Institution Recruiting
Paris Cedex 10, France, 75475
Contact: Site 1620         
Local Institution Recruiting
Pierre Bénite, France, 69495
Contact: Site 1618         
Local Institution Completed
Quimper, France, 29107
Local Institution Completed
Soissons cedex, France, 02209
Local Institution Completed
Strasbourg Cedex, France, 67065
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Site 1619         
Germany
Local Institution Active, not recruiting
Augsburg, Germany, 86156
Local Institution Active, not recruiting
Bochum, Germany, 44791
Local Institution Completed
Buxtehude, Germany, 21614
Local Institution Active, not recruiting
Chemnitz, Germany, 09117
Local Institution Completed
Darmstadt, Germany, 64297
Local Institution Completed
Dessau-Roblau, Germany, 06847
Local Institution Completed
Dortmund, Germany, 44137
Local Institution Active, not recruiting
Dresden, Germany, 01307
Local Institution Active, not recruiting
Düsseldorf, Germany, 40225
Local Institution Active, not recruiting
Erfurt, Germany, 99089
Local Institution Active, not recruiting
Erlangen, Germany, 91054
Local Institution Completed
Frankfurt, Germany, 60590
Local Institution Active, not recruiting
Freiburg, Germany, 79104
Local Institution Active, not recruiting
Gera, Germany, 07548
Local Institution Active, not recruiting
Göttingen, Germany, 37075
Local Institution Active, not recruiting
Halle/Saale, Germany, 06120
Local Institution Completed
Hamburg, Germany, 20099
Local Institution Active, not recruiting
Hamburg, Germany, 20246
Local Institution Completed
Hamburg, Germany, 20253
Local Institution Active, not recruiting
Hannover, Germany, 30625
Local Institution Active, not recruiting
Heidelberg, Germany, 69120
Local Institution Active, not recruiting
Jena, Germany, 07743
Local Institution Active, not recruiting
Kiel, Germany, 24105
Local Institution Completed
Koblenz, Germany, 56068
Local Institution Active, not recruiting
Ludwigshafen, Germany, 67063
Local Institution Active, not recruiting
Lübeck, Germany, 23538
Local Institution Active, not recruiting
Lüdenscheid, Germany, 58515
Local Institution Active, not recruiting
Magdeburg, Germany, 39120
Local Institution Active, not recruiting
Mainz, Germany, 55131
Local Institution Completed
Mannheim, Germany, 68167
Local Institution Completed
Marburg, Germany, 35043
Local Institution Active, not recruiting
Münster, Germany, 48149
Local Institution Completed
Plauen, Germany, 08529
Local Institution Completed
Quedlinburg, Germany, 06484
Local Institution Completed
Recklinghausen, Germany, 45657
Local Institution Completed
Rostock, Germany, 18055
Local Institution Active, not recruiting
Schwerin, Germany, 19049
Local Institution Completed
Schwäbisch Hall, Germany, 74523
Local Institution Completed
Stuttgart, Germany, 70374
Local Institution Active, not recruiting
Tübingen, Germany, 72076
Local Institution Active, not recruiting
Ulm, Germany, 89081
Local Institution Active, not recruiting
Würzburg, Germany, 97080
Greece
Local Institution Completed
Cholargos, Athens, Greece, 15562
Local institution Active, not recruiting
Goudi, Athens, Greece, 11527
Local Institution Active, not recruiting
Neo Faliro, Athens, Greece, 18547
Local Institution Active, not recruiting
Heraklion, Crete, Greece, 71100
Local Institution Completed
Neas Efkarpia, Thessaloniki, Greece, 56429
Local Institutio Completed
Alexandroupolis, Greece, 68100
Local Institution Completed
Athens, Greece, 11528
Local Institution Completed
Athens, Greece, 15233
Local Institution Completed
Mezourlo, Greece, 41334
Ireland
Local Institution Completed
Cork, Ireland
Local Institution Completed
Dublin, Ireland
Local Institution Active, not recruiting
Dublin, Ireland
Local Institution Active, not recruiting
Galway, Ireland
Local Institution Completed
Tullamore, Ireland
Israel
Local Institution Active, not recruiting
Beer Sheva, Israel, 84101
Local Institution Active, not recruiting
Haifa, Israel, 31096
Local Institution Active, not recruiting
Jerusalem, Israel, 91120
Local Institution Completed
Tel Aviv, Israel, 64239
Local Institution Active, not recruiting
Tel Hashomer, Israel, 52621
Poland
Local Institution Completed
Bydgoszcz, Poland, 85-796
Local Institution Active, not recruiting
Warszawa, Poland, 02-781
Local Institution Completed
Wrocław, Poland, 51-124
Local Institution Active, not recruiting
Łódź, Poland, 93-510
Spain
Local Institution Active, not recruiting
Barcelona, Spain, 08036
Local Institution Completed
Donostia, Spain, 20014
Local Institution Active, not recruiting
Las Palmas de Gran Canaria, Spain, 35016
Local Institution Completed
Madrid, Spain, 28007
Local Institution Active, not recruiting
Madrid, Spain, 28033
Local Institution Completed
Madrid, Spain, 28034
Local Institution Completed
Madrid, Spain, 28041
Local Institution Completed
Palma, Spain, 07198
Local Institution Completed
Pamplona, Spain, 31008
Local Institution Completed
Santa Cruz de Tenerife, Spain, 38010
Local Institution Completed
Santander, Spain, 39008
Local Institution Completed
Santiago de Compostela; A Coruña, Spain, 15706
Local Institution Completed
Sevilla, Spain, 41013
Local Institution Completed
Sta Cruz de Tenerife, Spain, 35320
Local Institution Active, not recruiting
Terrassa, Spain, 08027
Local Institution Active, not recruiting
Valladolid, Spain, 47012
Local Institution Active, not recruiting
Zaragoza, Spain, 50009
Switzerland
Local Institution Active, not recruiting
Baden, Switzerland, CH-5404
Local Institution Active, not recruiting
Basel, Switzerland, CH-4031
Local Institution Active, not recruiting
Lugano, Switzerland, CH-6900
Local Institution Completed
Zürich, Switzerland, CH-8091
United Kingdom
Local Institution Completed
Rhyl, Denbigshire, United Kingdom, LL18 5UJ
Local Institution Active, not recruiting
London, England, United Kingdom, NW3 2QG
Local Institution Completed
Chelmsford, Essex, Essex, United Kingdom, CM1 7ET
Local Institution Completed
Southend, Essex, United Kingdom, SS0 0RY
Local Institution Active, not recruiting
Belfast, Ireland, United Kingdom, BT9 7AB
Local Institution Active, not recruiting
St Helens., Merseyside, United Kingdom, WA9 3DA
Local Institution Active, not recruiting
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
Local Institution Active, not recruiting
Birmingham, United Kingdom, B15 2TH
Local Institution Active, not recruiting
Bristol, United Kingdom, BS2 8ED
Local Institution Active, not recruiting
Cambridge, United Kingdom, CB0 2QQ
Local Institution Completed
Exeter, United Kingdom, EX2 5DW
Local Institution Active, not recruiting
Hull, United Kingdom, HU16 5JQ
Local Institution Completed
Leeds, United Kingdom, LS9 7TF
Local Institution Active, not recruiting
Lincoln, United Kingdom, LN2 5QY
Local Institution Active, not recruiting
London, United Kingdom, SE1 9RT
Local Institution Active, not recruiting
London, United Kingdom, SW3 6JJ
Local Institution Active, not recruiting
Oxfordshire, United Kingdom, OX3 7LE
Local Institution Active, not recruiting
Plymouth, United Kingdom, PL6 8DH
Local Institution Active, not recruiting
Poole, United Kingdom, BH15 2JB
Local Institution Completed
Preston, United Kingdom, PR2 9HT
Local Institution Active, not recruiting
Staffordshire, United Kingdom, ST46QG
Local Institution Active, not recruiting
Taunton, Somerset, United Kingdom, TA1 5DA
Local Institution Active, not recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Local Institution Completed
Wirral, United Kingdom, CH63 4JY
Local Institution Completed
Wolverhampton, United Kingdom, WS13 6NH
Local Institution Completed
Yeovil, Somerset, United Kingdom, BA21 4AT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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 )
Study First Received: November 15, 2011
Last Updated: August 31, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017