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ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

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ClinicalTrials.gov Identifier: NCT02848274
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : May 2, 2019
Sponsor:
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02848274


Contacts
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Contact: Carol Bruce 650-804-4613 cabruce@stanford.edu

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Christiane Querfeld       cquerfeld@coh.org   
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94305
Contact: Carol Bruce    650-804-4613    cabruce@stanford.edu   
Principal Investigator: Youn Kim         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Vincent Liu       Vincent-liu@uiowa.edu   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Tatyana Feldman, MD       feldman@hackensackUMC.org   
United States, Pennsylvania
University of Pittsburg Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Oleg Akilov, MD       akilovoe@upmc.edu   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Heather Wickless       Heather.Wickless@UTSouthwestern.edu   
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: David Wada, MD       David.Wada@hsc.utah.edu   
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina
Contact: Paula Enz, MD       paula.enz@hospitalitaliano.org.ar   
Australia
Peter MacCallum Cancer Center, Recruiting
Melbourne, Australia
Contact: Miles Prince, MD       Miles.Prince@petermac.org   
Brazil
University of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil
Contact: Jose Sanches, MD       jasanches@usp.br   
China
Peking University First Hospital Recruiting
Beijing, China
Contact: Yang Wang, MD       wangyangdr@gmail.com   
Japan
The University of Tokyo Recruiting
Tokyo, Japan
Contact: Tomomitsu Miyagaki       asahikari1979@gmail.com   
United Kingdom
University Hospitals Birmingham Recruiting
Birmingham, United Kingdom
Contact: Julia Scarisbrick       Julia.scarisbrick@uhb.nhs.uk   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Youn Kim, MD Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02848274     History of Changes
Other Study ID Numbers: LYMNHL0134
IRB-32652 ( Other Identifier: Stanford IRB )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: February 2019

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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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Mycoses
Lymphoma
Lymphoma, Non-Hodgkin
Mycosis Fungoides
Sezary Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell