Cutaneous Squamous cell carcinoma (SCC) is a type of skin cancer. Some SCC may develop from areas of sun-damaged skin called actinic keratoses (AK), which arise on skin areas exposed to sunlight. Cancer
Conditions
Interventions
SPOT-IT Participants will be randomised to one of the following trial treatments:
Sunscreen + surveillance: Sunscreen with sun protection factor (SPF) 50+ will be applied daily as per the PI’s recomme
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: To be eligible for participation in this trial, the patient must: 1. Have a diagnosis of immunodeficiency being either organ or stem cell transplant recipient; haematological malignancy; long-term immunosuppressive medication for immune mediated inflammatory condition; living with human immunodeficiency virus infection (HIV) 2. Have history of at least one cSCC in the last 5 years 3. Be willing and able to provide written informed consent for the trial 4. Be willing and able to adhere to study procedures 5. Age 18 years or over on day of signing consent 6. For Organ Transplant Recipients (OTR): have stable transplanted organ function (transplant duration > 2 years) for at least 3 months prior to enrolment in the trial 7. No change in immunosuppressive medication in 3 months prior to enrolment in the trial
Exclusion criteria
Exclusion criteria: 1. Is unsuitable for treatment with topical 5FU or calcipotriol e.g. previously intolerant 2. Known disorders of calcium metabolism, including hypercalcaemia, or any condition that may predispose to elevated serum calcium levels 3. Known DPD (dihydropyrimidine dehydrogenase) deficiency 4. Severe renal or liver impairment 5. Has used topical 5FU or calcipotriol or other actinic keratosis (AK)-field treatment in the planned treatment zone within 8 weeks prior to enrolment in the trial 6. Has started treatment with mTOR inhibitors or systemic retinoids within 6 months prior to enrolment 7. Is participating in a clinical study with other Investigational Medicinal Products 8. Is pregnant or breastfeeding or planning to conceive or fathering children within the projected duration of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomisation to new primary cSCC arising in any of the three selected intervention zone(s): 1) neck, shawl, ± non-hair bearing scalp; 2) face and ears; 3) upper limbs measured using data recorded from randomisation to the time when a new primary cSCC is observed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. More effective treatment will be assessed in terms of time to new cSCC development within intervention zones from randomisation. 2. The impact of treatment of subsequent cSCC within and outside the intervention zone(s) will be evaluated in terms of time to onset and number of cSCC and non-cSCC skin cancers. 3. Local skin toxicity associated with each topical treatment from time to onset to resolution will be assessed through the collection of AEs, radiotherapy details, and concomitant medications as reported by clinicians on CRF and by participants on logbooks. 4. Participants’ experience and preference for each topical treatment will be assessed through logbooks throughout the trial and quality of life (QoL) questionnaires on Day 1 and month 4 of each treatment year, and at least annually for up to 4 years of follow-up. 5. Treatment’s effect on quality of life will be assessed through clinical reported clinical frailty on Day 1 of treatment in Y2-3 and at least annually for up to 4 years follow-up. 6. Cost-effectiveness of each topical treatment will be assessed through the QoL questionnaire and Resource use questionnaire on Day 1 and month 4 of each treatment year, and at least annually for up to 4 years of follow-up. | — |
Countries
United Kingdom, Wales
Contacts
Public ContactStudy contact -
Outcome results
None listed