Mycosis FungoidesNCT02848274
ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
An observational study of Mycosis Fungoides and Non-Hodgkin's Lymphoma, run by Stanford University at 13 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycosis Fungoides, Non-Hodgkin's Lymphoma
- How many people
- 2,000 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Oct 2016to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed with advanced stage mycosis fungoides and/or sezary syndrome
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 7 countries
United States7 sites, 7 recruiting
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Heather Wickless, Heather.Wickless@UTSouthwestern.edu
- Recruiting
City of Hope
Duarte, California, 91010
Christiane Querfeld, cquerfeld@coh.org
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Tatyana Feldman, MD, feldman@hackensackUMC.org
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Vincent Liu, Vincent-liu@uiowa.edu
- Recruiting
Stanford University, School of Medicine
Palo Alto, California, 94305
Tatiana Neal, 650-709-7838, tatianan@stanford.edu
Youn H Kim
- Recruiting
University of Pittsburg
Pittsburgh, Pennsylvania, 15260
Oleg Akilov, MD, akilovoe@upmc.edu
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
David Wada, MD, David.Wada@hsc.utah.edu
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
Paula Enz, MD, paula.enz@hospitalitaliano.org.ar
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Center,
Melbourne
Miles Prince, MD, Miles.Prince@petermac.org
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo Medical School
São Paulo
Jose Sanches, MD, jasanches@usp.br
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Yang Wang, MD, wangyangdr@gmail.com
Japan1 site, 1 recruiting
- Recruiting
The University of Tokyo
Tokyo
Tomomitsu Miyagaki, asahikari1979@gmail.com
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham
Birmingham
Julia Scarisbrick, Julia.scarisbrick@uhb.nhs.uk
About this study
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
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.
- Conditions
- Mycosis Fungoides, Non-Hodgkin's Lymphoma
- Medical subject headings
- Mycosis Fungoides, Lymphoma, Non-Hodgkin
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: date of diagnosis to death from any cause, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youn H Kim, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848274
- Sponsor's protocol ID
- IRB-32652
- Other IDs
- LYMNHL0134, NCI-2020-00940
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 2016
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scarisbrick JJ, Quaglino P, Whittaker S, Bagot M, Guenova E, Papadavid E, Prince HM, Sanches JA, Miyashiro DR, Servitje O, Querfeld C, Akilov O, Arumainathan A, Bennett L, Battistella M, Benstead K, Berti E, Beylot-Barry M, Busschots AM, Cowan R, Dummer R, Dunnill G, Estrach T, Evison F, Bashir A, Geskin L, Gru A, Guitart J, Herrera MC, Hodak E, Horwitz S, Jonak C, Klemke CD, Knobler R, Mckay P, Marschalko M, Massone C, Matin R, Mitteldorf C, Novoa R, Ortiz-Romero P, Pimpinelli N, Pujol RM, Ranki A, Vakeva L, Rieger KE, Stadler R, Trautinger F, Latzka J, Vermeer M, Wachsmuth R, Weatherhead S, Wehkamp U, Wobser M, Kim YH. A new prognostic index (CLIPI) for advanced cutaneous lymphoma enables precise patient risk stratification. Blood. 2025 Oct 2;146(14):1687-1692. doi: 10.1182/blood.2025029628.
PubMed 40663780
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02848274
- Acronym / sponsor ID
- IRB-32652
- Conditions
- Mycosis Fungoides, Non-Hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with advanced stage mycosis fungoides and/or sezary syndrome
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: date of diagnosis to death from any cause, up to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Derived from this study: PubMed 40663780Scarisbrick JJ, Quaglino P, Whittaker S, Bagot M, Guenova E, Papadavid E, Prince HM, Sanches JA, Miyashiro DR, Servitje O, Querfeld C, Akilov O, Arumainathan A, Bennett L, Battistella M, Benstead K, Berti E, Beylot-Barry M, Busschots AM, Cowan R, Dummer R, Dunnill G, Estrach T, Evison F, Bashir A, Geskin L, Gru A, Guitart J, Herrera MC, Hodak E, Horwitz S, Jonak C, Klemke CD, Knobler R, Mckay P, Marschalko M, Massone C, Matin R, Mitteldorf C, Novoa R, Ortiz-Romero P, Pimpinelli N, Pujol RM, Ranki A, Vakeva L, Rieger KE, Stadler R, Trautinger F, Latzka J, Vermeer M, Wachsmuth R, Weatherhead S, Wehkamp U, Wobser M, Kim YH. A new prognostic index (CLIPI) for advanced cutaneous lymphoma enables precise patient risk stratification. Blood. 2025 Oct 2;146(14):1687-1692. doi: 10.1182/blood.2025029628.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Youn H Kim, MD principal investigator
Stanford University
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycosis Fungoides and Non-Hodgkin's Lymphoma, run by Stanford University at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Argentina, Australia, Brazil, China and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Neal (650-709-7838, tatianan@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: date of diagnosis to death from any cause, up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.