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NCT02848274 Clinical Trial

ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02848274
Other study ID # IRB-32652
Secondary ID LYMNHL0134
Status Recruiting
Phase
First received
Last updated
Start date October 2016
Est. completion date March 2027

Study information
Verified date July 2023
Source Stanford University
Contact Tatiana Neal
Phone 650-709-7838
Email tatianan@stanford.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Australia Peter MacCallum Cancer Center, Melbourne
Brazil University of Sao Paulo Medical School Sao Paulo
China Peking University First Hospital Beijing
Japan The University of Tokyo Tokyo
United Kingdom University Hospitals Birmingham Birmingham
United States University of Texas Southwestern Dallas Texas
United States City of Hope Duarte California
United States Hackensack University Medical Center Hackensack New Jersey
United States University of Iowa Iowa City Iowa
United States Stanford University, School of Medicine Palo Alto California
United States University of Pittsburg Pittsburgh Pennsylvania
United States University of Utah Hospital Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Japan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) date of diagnosis to death from any cause, up to two years
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