Retrospective Study of Burden of Disease stage 3 Adjuvant Melanoma
Research type
Research Study
Full title
A Multi-Country Retrospective Chart Review Study of Burden of Disease for Patients with Stage III Adjuvant Melanoma
IRAS ID
224344
Contact name
Roy Kouth
Contact email
Sponsor organisation
Novartis Pharmaceuticals Corporation
Duration of Study in the UK
years, 2 months, days
Research summary
This study is looking back at the medical records of patients who have undergone surgical intervention for skin cancer which has spread to lymph nodes near to the tumour. This is known as stage III. Dependent on whether the lymph node tumour is visible, felt or has ulceration on the top layer of the skin will depict the severity or subclass of the disease. There are three subclasses for stage III melanoma. Subclass llla which has no ulceration and tiny tumour that are not visible to the naked eye. Subclass IIIb tumours that can be felt but again have no ulceration and Subclass IIIc tumour that may or may not have ulceration can be felt. The study will be looking at those patients who have stage IIIa through to stage IIIc who had adjuvant therapy . This is where they had treatment that was given after the initial treatment to reduce the risk of the melanoma coming back. \nTherapeutic options in the adjuvant setting remain limited and data on treatment patterns, patient characteristics, clinical outcomes and healthcare resource utilization are needed to understand the current treatment landscape and unmet needs in this patient population. This study aims to collect this information in order to understand this. The study aims to collect information from a total of 400 patients from several countries in North America and Europe. Medical records of patients will be selected irrespective of patient’s survival status at the time, the information will be extracted from medical records. The data will be retrieved from the existing electronic or paper medical patient records, administrative data, or hospital databases held by participating investigators. Data collected will be strictly anonymous. No patient identifying information will be requested in this study. Both academic and community-practice sites will be targeted. An effort will be made to achieve a broad geographic coverage.\n
REC name
London - Bloomsbury Research Ethics Committee
REC reference
17/LO/1268
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion