Understanding the burden and cost of managing progression of CTCL 1.0
Research type
Research Study
Full title
A Real-World Data study to understand the burden and cost of treating and managing progression of diagnosed Cutaneous T-cell lymphoma (CTCL).
IRAS ID
275540
Contact name
Richard Cowan
Contact email
Sponsor organisation
Kyowa Kirin Limited
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
Cutaneous T-Cell Lymphoma (CTCL) is a rare cancer primarily affecting the skin. CTCL typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. Progression from limited skin involvement may be accompanied by tumour formation, ulceration, and exfoliation – complicated by itching and infections, and which can cause significant pain and disfigurement. Advanced stages are defined by spread to the lymph nodes, peripheral blood, and internal organs, leading to a poor prognosis and resulting in reduced overall survival.
There is little published evidence in the UK that brings together the patient journey in terms of disease progression, treatment pathway, and overall healthcare resources utilised in the care and management of the patient. The present study aims to address this by reviewing historical data taken from the routine medical records of patients previously diagnosed with CTCL and who have been given at least one systemic therapy (suggestive that the disease has progressed beyond being managed with skin-directed therapy).
Two major NHS Centres that are part of the national skin lymphoma multidisciplinary network will identify a sample of eligible patients from their own patient records and extract only that patient data which is relevant for the study objectives. The study dataset created will comprise only of anonymised data and no identifiable patient data will be extracted.
Descriptive analyses will characterise the patients included in the sample, describe the course of their disease, and detail the treatments and healthcare resources used at each stage of the disease as it progresses. The intent is to publish this in the scientific literature and for the resource utilisation data to be included in a NICE Health Technology Assessment for a forthcoming new treatment, mogamulizumab.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0042
Date of REC Opinion
6 Feb 2020
REC opinion
Favourable Opinion