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An International Cutaneous Lymphoma Prognostic Index Model and the Impact of Major Therapies in Patients with Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome, PROCLIPI Study
Trial Status: active
This trial collects data from patients with stage IIB-IVB mycosis fungoides and Sezary syndrome to develop a prognostic index model to improve the care and management of patients with cutaneous lymphoma worldwide. Primary cutaneous lymphoma is a rare condition with diverse presentation and outcomes, and a robust biobank with quality clinical samples associated with exhaustive clinical and pathological data is important for impactful translational research in cutaneous lymphoma. The information gained from this research may help researchers to advance their knowledge of cutaneous lymphoma, specifically mycosis fungoides and Sezary syndrome, thereby improving the care of future patients.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02848274.
I. Determination of prognostic factors in advanced mycosis fungoides (MF) and Sezary syndrome (SS) in a prospective design.
II. Development of Cutaneous Lymphoma International Prognostic Index (CLIPI) towards improved prognostication and stratification for management in advanced MF and SS.
III. Characterization of geographic pattern of treatment utilization and CLIPI-based differential clinical outcome of major systemic treatments in advanced MF and SS.
IV. Development of federated biobank for Cutaneous Lymphoma International Consortium (CLIC) alliance projects.
OUTLINE:
The medical information of patients including clinical information related to their diagnosis of cutaneous lymphoma, clinical dates such as date of diagnosis, date of clinic visit, date of pathology reports, date of imaging reports, etc. are collected for study within 45 days of consent. Patients may be met every 3-6 months after initial diagnosis. Patients have the option to donate blood and tissue samples for the development of a biobank at the time of initial diagnosis and during follow-up.
After the completion of study, patients are followed up annually.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationStanford Cancer Institute Palo Alto
