Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study

  • UK Clinical Trials
  • Scotland

SPOT

london trials, uk clinical trials

SPOT Trial
Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)

Specialty : Cancer (co-adopted by Dermatology)
Portfolio Eligibility: Automatically eligible

ISRCTN 26398197
EudraCT 2013-000893-32
MREC N° 13/LO/1579
UKCRN ID 16962
WHO ID

Research Summary
A multi-centre, randomised, three arm, open-label, phase ll, feasibility study comparing topical treatment of actinic keratoses (AK) in OTR using 5-fluorouracil or 5% imiquimod (plus sunscreen) to standard care (sunscreen alone) in the prevention of squamous cell carcinoma (cSCC).
Study Type: Interventional
Design Type: Treatment
Disease(s):

Current Status: Open
Closure Date: 12/1/2016
Global Sample Size: 120
Global Recruitment to Date

Dermatology
Non-melanoma skin cancer (Squamous cell carcinoma)
Phase II

Geographical Scope UK Multi-Centre
Lead Country England (also active in Scotland)

Main Inclusion Criteria
1. Organ Transplant Recipient (OTR) Patient Group:
•OTRs aged >18 years
•A minimum of 10 AK (with at least 5 AK occurring within the same skin zone)
•Demonstrably stable renal function on the basis of serum creatinine and estimated Glomerular Filtration Rate (eGFR)
•No recent change in immunosuppressive medication and predicted to remain stable over course of the study
•Able to apply topical cream as directed to the required area or having a carer who agrees to do this at the required
frequency and times
•Women of childbearing
potential, or men in a relationship with a woman of childbearing
potential, prepared to adopt
adequate contraceptive measures if sexually active
•Able to give written informed consent
•Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
2. Immunocompetent Patient Group (participating in the DCE substudy only):
•ICP patients aged >18 years
•Present or previous AK (any site, any number)
•Able to give written informed consent
•Willing to spend up at least 20 minutes completing the Long Q

Further details, please contact
Miss Georgina Dotchin

Cancer Research UK Clinical Trials Unit
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
UNITED KINGDOM

Tel: 01214149247
g.dotchin@bham.ac.uk

Miss Claire Gaunt

University of Birmingham
Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
West Midlands
B15 2TT
UNITED KINGDOM

Tel: 0121 414 3057
Fax: 0121 414 8392
C.H.Gaunt@bham.ac.uk

To apply for this job please visit the following URL: http://www.nottingham.ac.uk/research/groups/cebd/projects/help-trial/index.aspx →