A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review (METER)

December 7, 2023 updated by: AbbVie

A Multi-Country, Real-World Study to Explore Treatment Patterns, Effectiveness and Healthcare Resource Utilization for Patients Diagnosed With Myelofibrosis Through Chart Review

Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs) in which bone marrow cells that produce blood cells develop and function abnormally. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with Myelofibrosis.

Data from approximately 1000 participants will be collected. No participants will be enrolled in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 156 weeks.

There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 156 weeks.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

998

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Instituto FIDES /ID# 245526
    • Ciuadad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 244373
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1114
        • Fundaleu /Id# 244371
  • Australia
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Townsville University Hospital /ID# 246585
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 246583
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 246584
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital /ID# 246586
  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 247392
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05652-900
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 247394
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital /ID# 249719
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health /ID# 248393
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre /ID# 251334
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre /ID# 249748
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 250449
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 250563
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital /ID# 250674
  • Colombia
      • Cali, Colombia, 760042
        • Clínica Imbanaco S.A.S /ID# 248465
      • Medellin, Colombia, 50034
        • Hospital Pablo Tobon Uribe /ID# 244525
    • Atlantico
      • Baranquilla, Atlantico, Colombia, 080016
        • Organizacion Clinica Bonnadona -PREVENIR S.A.S. /ID# 244589
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 11011
        • Fundacion Santa Fe de Bogota /ID# 244588
      • Bogota DC, Cundinamarca, Colombia, 111221
        • Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 246108
  • Greece
      • Alexandroupolis, Greece, 68100
        • General University Hospital of Alexandroupolis /ID# 246161
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 246165
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 246160
      • Piraeus, Greece, 18737
        • METAXA Cancer Hospital of Piraeus /ID# 246164
      • RION Patras Achaia, Greece, 26504
        • University General Hospital of Patras /ID# 246162
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 246159
      • Athens, Attiki, Greece, 12462
        • University General Hospital Attikon /ID# 246167
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 246163
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 245716
      • Brescia, Italy, 25123
        • ASST Spedali civili di Brescia /ID# 244910
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244909
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 245566
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 245075
      • Varese, Italy, 21100
        • ASST Sette Laghi /ID# 245443
      • Viterbo, Italy, 01100
        • Ospedale Belcolle /ID# 245726
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 245149
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 245335
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Azienda Ospedaliera di Perugia /ID# 245415
  • Mexico
      • Ciudad de Mexico, Mexico, 06720
        • Hospital General de Mexico /ID# 244749
    • Ciudad De Mexico
      • Ciudad de México, Ciudad De Mexico, Mexico, 06720
        • Hospital de Especialidades CMN SigloXXI /ID# 244748
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64610
        • Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 244750
  • Poland
      • Orzesze, Poland, 43-180
        • Specjalistyczna Praktyka Lekarska Grzegorz Helbig /ID# 250515
      • Łódź, Poland, 90-712
        • Joanna Góra-Tybor Specjalistyczna Praktyka Lekarska /ID# 250495
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-309
        • Krzysztof Mądry Praktyka Lekarska /ID# 250485
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-337
        • Specjalistyczna Praktyka Lekarska Witold Prejzner /ID# 250516
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitario de Coimbra, EPE /ID# 244687
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 248203
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 244400
  • Romania
      • Bucharest, Romania, 925200
        • Institutul Clinic Fundeni /ID# 245939
      • Bucuresti, Romania, 020121
        • Spitalul Clinic Colentina /ID# 245620
      • Cluj Napoca, Romania, 400015
        • Institutul Oncologic Prof Dr I Chiricuta /ID# 244393
    • Brasov
      • Brașov, Brasov, Romania, 500152
        • MedLife - Policlinica de Diagnostic Rapid /ID# 244395
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 250092
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital /ID# 250093
  • Turkey
      • Ankara, Turkey, 06010
        • Gulhane Askeri Tip Academy /ID# 244134
      • Ankara, Turkey, 06230
        • Hacettepe University Medical Faculty /ID# 244131
      • Diyarbakir, Turkey, 21200
        • Dicle Universitesi Tip /ID# 244137
      • Edirne, Istanbul, Turkey, 22030
        • Trakya University Medical Facu /ID# 244132
      • Istanbul, Turkey, 34214
        • Bagcilar Medipol Mega Universite Hastanesi /ID# 244133
      • Izmir, Turkey, 35040
        • Ege University Medical Faculty /ID# 244130
      • Malatya, Turkey, 44280
        • Inonu University Medical Faculty /ID# 244135
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1932
        • UAB Comprehensive Cancer Center /ID# 252767
    • California
      • West Hills, California, United States, 91307-1468
        • Wellness Oncology & Hematology /ID# 255591
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital /ID# 254312
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research /ID# 252768

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants patients diagnosed with myelofibrosis and treated on or after the first date when ruxolitinib was approved in their country of residence and no later than 31 December 2021.

Description

Inclusion Criteria:

  • Treated for myelofibrosis (MF) [primary myelofibrosis (PMF) and secondary myelofibrosis (SMF)].
  • Must have initiated their first treatment on or after the first date when ruxolitinib was approved in their country of residence and no later than 31 December 2021.

Exclusion Criteria:

- Having received MF treatment in a clinical trial setting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Participants Undergoing Chart Review
Participants treated for myelofibrosis undergoing chart review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from Diagnosis of Myelofibrosis (MF) to Initial Treatment
Time Frame: Up to Week 156
Time from diagnosis of MF to initial treatment.
Up to Week 156
Duration of Initial Treatment
Time Frame: Up to Week 156
Duration of initial treatment.
Up to Week 156
Duration of Second Treatment
Time Frame: Up to Week 156
Duration of second treatment.
Up to Week 156
Duration of Subsequent Treatments
Time Frame: Up to Week 156
Duration of subsequent treatments.
Up to Week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2022

Primary Completion (Actual)

November 14, 2023

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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