Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02848274




Registration number
NCT02848274
Ethics application status
Date submitted
25/07/2016
Date registered
28/07/2016
Date last updated
19/07/2023

Titles & IDs
Public title
ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
Scientific 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
Secondary ID [1] 0 0
LYMNHL0134
Secondary ID [2] 0 0
IRB-32652
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mycosis Fungoides 0 0
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
date of diagnosis to death from any cause, up to two years

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center, - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
Japan
State/province [10] 0 0
Tokyo
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Other
Name
Stanford University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02848274
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Youn H Kim, MD
Address 0 0
Stanford University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tatiana Neal
Address 0 0
Country 0 0
Phone 0 0
650-709-7838
Fax 0 0
Email 0 0
tatianan@stanford.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02848274