Prospective observational international registry of patients with newly diagnosed peripheral t cell lymphoma - T-cell Project 2.0

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Osservazionale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- Diagnosis of:
    - EBV-positive T-cell and NK-cell lymphoproliferative diseases of childhood
    - Mycosis fungoides;
    - Sézary syndrome;
    - Primary cutaneous CD30-positive T-cell lymphoproliferative disorders;
    - Primary cutaneous peripheral T-cell lymphomas, rare subtypes;
    - T-cell lymphoblastic lymphoma/leukemia
    - T-cell prolymphocitic leukemia
- Age < 18.

Trattamento sperimentale: 

NA

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

To verify whether a prospective collection of data would allow more accurate information on T-cell lymphomas to be achieved.
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 the most
optimal treatment strategies for these neoplasms in the real-world population.

Obiettivi secondari dello studio: 

Moreover, from a molecular point of view, the objective of the study is to estimate prospectively the frequency of pEBVd
detection in our cohort of PTCL patients at baseline and at the end of initial therapy, to characterize agreement between pEBVd and EBER in tumor tissue, and to explore the prognostic or predictive implications of detectable pEBVd in PTCL. Finally, to investigate the genetics and pathogenic mechanisms of aggressive PTCLs on an international scale.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03964480

Data di inserimento: 23.11.2021

Promotore

Associazione Angela Serra per la ricerca sul cancro

Principal Investigator ITALIA

Università di Modena e Reggio Emilia
Centro Oncologico Modenese, Modena

Riferimento: Prof. Massimo Federico

Telefono: 0594225515

Email: massimo.federico@unimore.it

Localita: Modena