Advanced Stage PROCLIPI

The main objective of the PROCLIPI (Prospective Cutaneous Lymphoma International Prognostic Index) Study is to collect and share data on patients with cutaneous lymphoma. Cutaneous T cell lymphoma (CTCL) is recognized not only as a rare/orphan disease, but also a heterogeneous entity in clinical presentation, histopathology, and molecular features. The current staging does not accurately stratify patients according to survival. This study is aimed at identifying prognostic markers to develop a prognostic index, which will augment clinical staging and can be utilized for risk stratification in clinical management or therapeutic trials. Because of the rarity of this disease only an international collaboration will power such a study. To this end, the international community of experts in cutaneous lymphoma has formed an unprecedented large-scale collaborative alliance, the Cutaneous Lymphoma International Consortium (CLIC), to establish an efficient conduit where well defined prospective data are captured using a standard protocol.

Site requirements for participation in the PROCLIPI study:

  1. Each participating site must aim to complete and capture 100% of the required dataset and encouraged to complete and capture information in the exploratory dataset.
  2. Each participating site will have at least one dedicated pathologist to review the pathology data (derm and hematopath) prior to transfer to the primary data center for upload. The site pathologist will ensure that the path data meets the definition and criteria specified in the PROCLIPI protocol.
  3. Each site will have at least one designated data coordinator for effective resolution of any data queries or maintenance of the site’s regulatory binder.

Federated (“virtual”) Biobank SOP, encouraged at all participating sites