Sarcopenia and outcomes in patients diagnosed with penile cancer
Research type
Research Study
Full title
Assessing Sarcopenia and morbidity and mortality outcomes in metastatic and non-metastatic penile cancer
IRAS ID
182209
Contact name
Michelle Christodoulidou
Contact email
Clinicaltrials.gov Identifier
15/0396, R&Dnumber
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Introduction
Penile cancer is a rare disease with an incidence of 1:100 000 in Europe. There is very little evidence in the current literature investigating sarcopenia in patients with penile cancer and whether it affects their disease specific prognosis and morbidity related to surgical treatment and chemo-radiotherapy interventions.
Aim
The aim of this study is to investigate whether sarcopenia is related to morbidity and whether it can be used as a predictive factor for metastatic disease, prognosis and response to chemo-radiotherapy treatment in patients with metastatic and non-metastatic penile cancer.
Place of study
University College London Hospital as a tertiary centre, receives patients from London, Surrey and Reading and therefore has approximately 80 new penile cancer referrals per year.
Study Design
Case-controlled retrospective observational study
Cohorts
We will identify the cohorts from a UCLH dataset of patients diagnosed with penile cancer and treated in our unit since 2005.
This study will have two patient cohorts; 50 patients diagnosed with metastatic penile cancer treated with either chemotherapy or radiotherapy, and 50 patients with non-metastatic cancer who had no evidence of local or regional recurrence on follow up after treatment of their primary lesion.
Objectives
Primary objective: We will assess whether sarcopenia is associated with decreased overall survival.
Secondary objectives: We will review if there is any association between sarcopenia and; chemotherapy toxicity, radiotherapy complications and post-operative complications in patients receiving treatment for penile cancer.
Methodology
Sarcopenia will be assessed by importing pseudo-anonymised Computerised Tomography Images (Slices Lumbar L3 and L4/5) to a specialised software in measuring body composition. According to international consensus, sarcopenia is classified as a skeletal muscle index of <55cm2/m2 for men. These results will be validated with a nutritional team from University of Manchester with expertise in this area. Sarcopenia will then be correlated with patients’ clinical outcomes.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0421
Date of REC Opinion
15 Sep 2015
REC opinion
Favourable Opinion