Chart review in Cutaneous T-cell lymphoma
Research type
Research Study
Full title
Real-world treatment patterns and outcomes in relapsed/refractory cutaneous T-cell lymphoma (CTCL) following systemic therapy in Germany, France and the UK: A chart review study
IRAS ID
227125
Contact name
Julia Scarisbrick
Contact email
Sponsor organisation
Takeda UK Limited
Duration of Study in the UK
0 years, 8 months, 15 days
Research summary
Cutaneous T-cell lymphoma (CTCL) is a rare form of skin cancer, and its incidence has been steadily increasing over time in Europe. CTCL is a challenging disease to treat due to multi-organ involvement (including the blood, viscera, lymph nodes, and skin) and progression of disease. Patients typically start treatment with skin-directed therapies and move on to systemic therapies (including chemotherapies) as the disease progresses to more advanced stages. Often patients relapse to systemic therapy or become refractory to those therapies. Following failure to systemic therapy or repeated systemic therapies, patient may have no other option then going through a stem cell transplant or enter a clinical trial. A complex team of physicians including dermatologists, oncologists, and haematologists is often required to treat these patients during the course of the disease.
This study is being conducted to investigate what is the standard of care of patients with CTCL who have relapsed or have become refractory to systemic therapy in the United Kingdom, France, and Germany.
The data for this study will be collected from the medical charts of patients who have been treated by physicians with specialities in dermatology, haematology and oncology during their routine clinical practice. All the data will be collected retrospectively going backward from January 1, 2016 to possibly as far back as 2010 to identify approximately 5 charts. Once the chart is identified, data will be extracted from the chart by the treating physician or his/her assistant from the time of diagnosis to January 2017 or time of death whichever occurred first.
The physician will collect demographic data (age [year of birth], gender, ethnicity), clinical data (diagnosis, comorbidities, skin symptoms, serology, immunochemistry), treatment (type of treatment, response to treatment), and survival.
The study is an observational study using medical data collected in the past by the treating physician, with no impact on the patient. The patient personal health information will be kept in secure, limited-access files at the participating physicians’ offices and will be used only to identify potential cases for study inclusion and to retrieve medical record data for the purpose of case verification and only accessible to the hospital personnel. Neither sponsor nor sponsor's representatives, monitors will have direct access to patients' medical records. The patients’ charts will be de-identified and these de-identified data will be exported out of the European Union. The data will be analysed by a statistician working on behalf of the sponsor in Canada.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/0892
Date of REC Opinion
25 May 2017
REC opinion
Favourable Opinion