Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

This study T-Cell Project 2.0 is based on the former International PTCL study designed by the International T-cell Non-Hodgkin's Lymphoma Study Group (T-Cell Project 1.0: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma) as a prospective collection of data to predict the prognosis of patients with the more frequent subtypes of PTCL. It is a prospective, longitudinal, international, observational study of patients with newly diagnosed peripheral T-cell lymphoma aiming to verify whether this prospective collection of data would allow achieving a more accurate information on T-cell lymphomas. The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population as well as molecular markers and to explore the prognostic or predictive implications of them in PTCL. The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma:

‣ T-cell large granular lymphocytic leukaemia;

⁃ Chronic lymphoproliferative disorder of NK cells;

⁃ Aggressive NK-cell leukaemia;

⁃ Adult T-cell leukaemia/lymphoma;

⁃ Extranodal NK/T-cell lymphoma, nasal type;

⁃ Intestinal T-cell lymphoma;

⁃ Hepatosplenic T-cell lymphoma;

⁃ Subcutaneous panniculitis-like T-cell lymphoma;

⁃ Peripheral T-cell lymphoma, not otherwise specified;

⁃ Angioimmunoblastic T-cell lymphoma and other nodal lymphomas of T follicular helper cell origin;

⁃ Anaplastic large cell lymphoma, ALK-positive;

⁃ Anaplastic large cell lymphoma, ALK-negative;

⁃ Breast implant-associated anaplastic large cell lymphoma.

• Age 18 and over;

• Tissue biopsy adequate for diagnosis and classification and available for centralized review;

• Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 2 years are requested;

• Written informed consent.

Locations
United States
California
Stanford University
NOT_YET_RECRUITING
Stanford
Other Locations
Italy
IRCCS Istituto Tumori Giovanni Paolo II
RECRUITING
Bari
Palermo_La Maddalena
NOT_YET_RECRUITING
Palermo
Terni-Santa Maria
NOT_YET_RECRUITING
Terni
Romania
Cluj Napoca_Ion Chiricuta Oncology Institute
RECRUITING
Cluj-napoca
Ukraine
National Cancer Institute
RECRUITING
Kiev
Contact Information
Primary
Martina Manni, MSc, PhD
marmanni@unimore.it
+390594223284
Backup
Athina Lymboussakis, MSc, PhD
athina.lymboussakis@unimore.it
+390594223143
Time Frame
Start Date: 2018-10-14
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 1000
Sponsors
Leads: Associazione Angela Serra per la ricerca sul cancro

This content was sourced from clinicaltrials.gov