SPOT Trial v 1.0 (13th June 2013)
Research type
Research Study
Full title
Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)
IRAS ID
116319
Contact name
Catherine Harwood
Contact email
Sponsor organisation
Barts Health NHS Trust
Eudract number
2013-000893-32
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Squamous cell carcinoma (cSCC) is a very common skin cancer. Many people affected develop multiple cSCC requiring repeated surgery that may be disfiguring. cSCC causes over 20% of skin cancer-related deaths, and economically is placing an ever increasing economic burden on the NHS. Actinic keratoses (AK) are common skin lesions, affecting a quarter of the UK population over 60 years of age. They are potentially precancerous lesions for cSCC. Treatment of AK may prevent development of cSCC. Organ transplant recipients (OTR) have a very high (100-fold) increased risk of developing cSCC rapidly from AK. This makes them an ideal patient group for looking at the treatment of AK and cSCC prevention.
The aim of SPOT is to determine whether it is feasible to perform a large, national, randomised controlled (so called phase III) trial evaluating prevention of cSCC using currently available AK treatments. Sixty OTR will be randomised into one of 3 groups: 5-fluorouracil cream with discretionary sunscreen, imiquimod with discretionary sunscreen or discretionary sunscreen only (control). Patients will receive two 4-week treatment periods, with a 4-week gap, and will be followed-up for 12 months. AK clearance (the primary endpoint), development of cSCC, tolerability of treatment and quality of life will be measured. Photographs will also be used to assess AK clearance. The acceptability of treatment will be determined using a decision choice questionnaire. In addition to the OTR randomised into SPOT 60 immunocompetent patients will be asked to complete this questionnaire to assess treatment preference.
This study will pave the way for the large phase III trial needed to provide robust evidence that one/both of these treatments provides cost effective cancer prevention. The potential benefits are enormous and we predict that a successful outcome would see this treatment becoming an important tool in the fight against skin cancer.REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1579
Date of REC Opinion
17 Feb 2014
REC opinion
Further Information Favourable Opinion