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ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02848274
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2020
Information provided by (Responsible Party):
Stanford University

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
Mycosis Fungoides Non-Hodgkin's Lymphoma

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Study Type : Observational
Estimated 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 : October 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: date of diagnosis to death from any cause, up to two years ]

Biospecimen Retention:   Samples With DNA
tissue, blood

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with advanced stage mycosis fungoides and/or sezary syndrome

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.

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 identifier (NCT number): NCT02848274

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Contact: Tatiana Neal 650-709-7838

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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Christiane Querfeld   
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94305
Contact: Tatiana Neal    650-709-7838   
Principal Investigator: Youn H Kim         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Vincent Liu   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Tatyana Feldman, MD   
United States, Pennsylvania
University of Pittsburg Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Oleg Akilov, MD   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Heather Wickless   
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: David Wada, MD   
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina
Contact: Paula Enz, MD   
Peter MacCallum Cancer Center, Recruiting
Melbourne, Australia
Contact: Miles Prince, MD   
University of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil
Contact: Jose Sanches, MD   
Peking University First Hospital Recruiting
Beijing, China
Contact: Yang Wang, MD   
The University of Tokyo Recruiting
Tokyo, Japan
Contact: Tomomitsu Miyagaki   
United Kingdom
University Hospitals Birmingham Recruiting
Birmingham, United Kingdom
Contact: Julia Scarisbrick   
Sponsors and Collaborators
Stanford University
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Principal Investigator: Youn H Kim, MD Stanford University
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Responsible Party: Stanford University Identifier: NCT02848274    
Other Study ID Numbers: LYMNHL0134
IRB-32652 ( Other Identifier: Stanford IRB )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycosis Fungoides
Sezary Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell