ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

July 17, 2023 updated by: Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • Argentina
  • Australia
  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • University of Sao Paulo Medical School
        • Contact:
  • China
      • Beijing, China
  • Japan
  • United Kingdom
  • United States
    • California
      • Duarte, California, United States, 91010
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University, School of Medicine
        • Contact:
        • Principal Investigator:
          • Youn H Kim
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Recruiting
        • University of Pittsburg
        • Contact:
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with advanced stage mycosis fungoides and/or sezary syndrome

Description

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 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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: date of diagnosis to death from any cause, up to two years
date of diagnosis to death from any cause, up to two years

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

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

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)

October 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimated)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-32652
  • LYMNHL0134 (Other Identifier: OnCore)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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