T-cell Project 2.0_Version 1.0 – June 18, 2018
Research type
Research Study
Full title
PROSPECTIVE OBSERVATIONAL INTERNATIONAL COHORT STUDY OF PATIENTS WITH NEWLY DIAGNOSED PERIPHERAL T CELL LYMPHOMA.
IRAS ID
269926
Contact name
Christopher Fox
Contact email
Sponsor organisation
Associazione Angela Serra per la Ricerca sul Cancro
Clinicaltrials.gov Identifier
NCT03964480, ClinicalTrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 12 days
Research summary
T-cell Project 2.0 is a prospective observational cohort study, enrolling patients with newly diagnosed T cell Non-Hodgkin lymphoma (rare cancers arising from mature T cells and Natural Killer (NK) cells). By studying consecutively diagnosed patients with this rare and heterogeneous group of blood cancer, this research builds on the success of the previous T cell project by responding to changes made in diagnosis, classification, staging and response evaluation witnessed over the past 5-10 years. The aim is to gain a contemporary understanding of the evolving landscape of clinical, pathobiological, radiological and therapeutic aspects of T-cell lymphoma in order to inform future clinical management from refined diagnosis through to targeted therapy.
This is a prospective, longitudinal, international, observational study of patients with histological diagnosis of Peripheral T-cell lymphoma. Eligible patients will be identified through existing clinical pathways at participating hospitals. No additional hospital visits or additional procedures will be required from patients participating in the study. Patients will be asked to provide informed consent for relevant clinical data to be recorded and analysed. Patients will also be asked to provide separate consent for additional analyses of biological samples including the existing stored diagnostic tumour tissue (no additional biopsies will be performed) as well as additional blood tests (additional blood taken at the same time as standard clinical blood tests). Patients will be treated and evaluated according to the physician’s standard practice. While patients may receive experimental interventions in the course of their care, the Registry is not designed to test any specific intervention. The study is planned to complete accrual in 2.5 years with a minimum follow-up of 2 years for each patient registered; required for the final analysis of study endpoints.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0060
Date of REC Opinion
23 Feb 2021
REC opinion
Favourable Opinion