Skin cancer prevention in people who have had organ transplants by the use of treatment creams to get rid of actinic keratosis skin lesions (cancer precursors)- does this work?

Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT) - SPOT Trial v 1.0 (13th June 2013)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000893-32-GB

Enrollment

120

Registered

2013-10-21

Start date

2014-02-17

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis (and cutaneous squamous cell carcinoma) MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Aldara Product Name: Imiquimod Pharmaceutical Form: Cream INN or Proposed INN: imiquimod CAS Number: 99011-02-6

Eligibility

Sex/Gender

All

Inclusion criteria

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 child-bearing potential, or men in a relationship with a woman of child-bearing 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Organ Transplant Recipients (OTR) only: •Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin (hCG) test performed to rule out pregnancy prior to trial entry) •Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible •Life expectancy less than 12 months •Known hypersensitivity to 5-fluorouracil, imiquimod, sunscreen, or to any of the excipients (including but not limited to: methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, stearyl alcohol, polysorbate 60, propylene glycol, methyl parahydroxybenzoate and white soft paraffin) •The use of brivudine, sorivudine and analogues is prohibited

Design outcomes

Primary

Measure	Time frame
Main Objective: Cutaneous squamous cell carcinoma (cSCC) is economically a major burden to the NHS. The incidence is rising rapidly, with approximately 30,000 new cases per year in the UK. Immunosuppressed organ transplant recipients (OTR) have a more than 100-fold increased risk and an accelerated carcinogenic process, making them an ideal population in which to test interventions aimed at preventing cSCC. Premalignant lesions, termed actinic keratoses (AK), are present on sun-damaged skin and effective topical agents are available to treat them. The close relationship between AK and cSCC means that such topical treatment of a field bearing multiple AK should significantly reduce subsequent risk of developing cSCC, but this assumption has never been proven. The main objective of the study is thus to determine the feasibility of performing a larger phase III randomised controlled trial using topical treatment of AK as a strategy for prevention of invasive cSCC. The decision to perform a phase III ra ; Secondary Objective: 1. To assess the activity of the treatment cream, determined by the clearance of AK at the end of the treatment period, the persistence of that clearance at the end of month 12, and the development of cSCC at 12 months after treatment. 2. To develop and evaluate an objective clinical system for measuring AK, taking into account lesion size, erythema (redness), hyperkeratosis (dry and scaly texture) and whether the AK appear as a continuous field. In addition, AK diagnosis by clinicians using the system described above will be compared to an independent photographic assessment of AK to determine the level of agreement between the two methods and the utility of photographs as a means of measuring AK. 3. Patient centred secondary objectives include ascertaining patient treatment preference and testing the sensitivity of QoL instruments in advance of a larger trial.	—

Measure

Time frame

Main Objective: Cutaneous squamous cell carcinoma (cSCC) is economically a major burden to the NHS. The incidence is rising rapidly, with approximately 30,000 new cases per year in the UK. Immunosuppressed organ transplant recipients (OTR) have a more than 100-fold increased risk and an accelerated carcinogenic process, making them an ideal population in which to test interventions aimed at preventing cSCC. Premalignant lesions, termed actinic keratoses (AK), are present on sun-damaged skin and effective topical agents are available to treat them. The close relationship between AK and cSCC means that such topical treatment of a field bearing multiple AK should significantly reduce subsequent risk of developing cSCC, but this assumption has never been proven. The main objective of the study is thus to determine the feasibility of performing a larger phase III randomised controlled trial using topical treatment of AK as a strategy for prevention of invasive cSCC. The decision to perform a phase III ra ; Secondary Objective: 1. To assess the activity of the treatment cream, determined by the clearance of AK at the end of the treatment period, the persistence of that clearance at the end of month 12, and the development of cSCC at 12 months after treatment. 2. To develop and evaluate an objective clinical system for measuring AK, taking into account lesion size, erythema (redness), hyperkeratosis (dry and scaly texture) and whether the AK appear as a continuous field. In addition, AK diagnosis by clinicians using the system described above will be compared to an independent photographic assessment of AK to determine the level of agreement between the two methods and the utility of photographs as a means of measuring AK. 3. Patient centred secondary objectives include ascertaining patient treatment preference and testing the sensitivity of QoL instruments in advance of a larger trial.

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Secondary

Measure	Time frame
Secondary end point(s): 1. The activity outcome measures will be determined by the following criteria: •Clearance of AK trial treatment field(s): defined as the proportion of AKs identified at baseline that are no longer detectable at 4 and 8 weeks post treatment •Persistence of AK clearance trial treatment field(s): defined as the proportion of AKs which were cleared at 4 and 8 weeks post treatment which remain undetectable at the completion of the 12 month follow-up period •Development of cSCC: defined as the time from entry into the trial until development of cSCC. Patients will be censored at the date last seen alive without development of cSCC. 2. The evaluation outcome measures will be determined by the following criteria: •Evaluation of the proposed overall AK quantification scoring criteria: defined as scores designated for lesion size (including area of contiguous field change), erythema and hyperkeratosis •Measure concordance of AK diagnosis by clinicians: defined as assessing the concordance of clinicians scores vs the scores from the paired photographic assessments. 3. The patient-centred outcome measures will be determined by: •Patient treatment preferences: defined as the preference weights or relative values put on the various treatment attributes (duration of treatment, frequency of application, severity of reaction; improvement in appearance, reduction in skin cancer risk) •Assessment of QoL measure: defined as differences between patient QoL scores before, during and after treatment and between alternative treatments. ;Timepoint(s) of evaluation of this end point: As above, for evaluation of primary endpoint.	—

Measure

Time frame

Secondary end point(s): 1. The activity outcome measures will be determined by the following criteria: •Clearance of AK trial treatment field(s): defined as the proportion of AKs identified at baseline that are no longer detectable at 4 and 8 weeks post treatment •Persistence of AK clearance trial treatment field(s): defined as the proportion of AKs which were cleared at 4 and 8 weeks post treatment which remain undetectable at the completion of the 12 month follow-up period •Development of cSCC: defined as the time from entry into the trial until development of cSCC. Patients will be censored at the date last seen alive without development of cSCC. 2. The evaluation outcome measures will be determined by the following criteria: •Evaluation of the proposed overall AK quantification scoring criteria: defined as scores designated for lesion size (including area of contiguous field change), erythema and hyperkeratosis •Measure concordance of AK diagnosis by clinicians: defined as assessing the concordance of clinicians scores vs the scores from the paired photographic assessments. 3. The patient-centred outcome measures will be determined by: •Patient treatment preferences: defined as the preference weights or relative values put on the various treatment attributes (duration of treatment, frequency of application, severity of reaction; improvement in appearance, reduction in skin cancer risk) •Assessment of QoL measure: defined as differences between patient QoL scores before, during and after treatment and between alternative treatments. ;Timepoint(s) of evaluation of this end point: As above, for evaluation of primary endpoint.

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Countries

United Kingdom

Contacts

Public ContactDr Joshua Savage

Cancer Research UK Clinical Trials Unit (CRCTU)

SPOT@trials.bham.ac.uk0121 4149247

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026