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ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02848274
Collaborator
(none)
2,000
Enrollment
13
Locations
124.9
Anticipated Duration (Months)
153.8
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients With Advanced Mycosis Fungoides and Sézary Syndrome
    Actual Study Start Date :
    Oct 1, 2016
    Anticipated Primary Completion Date :
    Mar 1, 2027
    Anticipated Study Completion Date :
    Mar 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [date of diagnosis to death from any cause, up to two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Diagnosis of advanced stage MF or SS (Stages IIB - IVB) within 6 months of presentation to the participating center

    • Patients that are expected to have care administered at the participating center or jointly with referring physician(s) where follow-up data would be available

    Exclusion Criteria

    • Patients diagnosed with early stage MF/SS (Stages IA-IIA) before progressing to advanced stage

    • Patients diagnosed with advanced MF/SS more than 6 months prior to initial presentation to the participating center

    • Exclude one-time consultation type of new patients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 Stanford University, School of Medicine Palo Alto California United States 94305
    3 University of Iowa Iowa City Iowa United States 52242
    4 Hackensack University Medical Center Hackensack New Jersey United States 07601
    5 University of Pittsburg Pittsburgh Pennsylvania United States 15260
    6 University of Texas Southwestern Dallas Texas United States 75390
    7 University of Utah Hospital Salt Lake City Utah United States 84132
    8 Hospital Italiano de Buenos Aires Buenos Aires Argentina
    9 Peter MacCallum Cancer Center, Melbourne Australia
    10 University of Sao Paulo Medical School Sao Paulo Brazil
    11 Peking University First Hospital Beijing China
    12 The University of Tokyo Tokyo Japan
    13 University Hospitals Birmingham Birmingham United Kingdom

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Youn H Kim, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT02848274
    Other Study ID Numbers:
    • IRB-32652
    • LYMNHL0134
    First Posted:
    Jul 28, 2016
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Lymphoma
    Mycosis Fungoides
    Sezary Syndrome

    Study Results

    No Results Posted as of Jun 21, 2022