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Trial registered on ANZCTR


Registration number
ACTRN12616000876493
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
5/07/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Actinic Keratosis and Squamous Cell Carcinoma Cross-sectional Microbiome study in Transplant Recipients
Scientific title
A cross-sectional study to determine whether certain microbiome on the skin influence the progression of sun-damaged skin to skin cancer in immune-supressed transplant recipients.
Secondary ID [1] 289518 0
None
Universal Trial Number (UTN)
U1111-1184-5666
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma 299227 0
Actinic Keratosis 299228 0
Condition category
Condition code
Skin 299236 299236 0 0
Dermatological conditions
Cancer 299360 299360 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be recruited during routine follow up visits concerning previous renal/liver transplant.

Participation involves one visit with the study team where a full skin check will be performed. Swabs will be taken from standardised control sites of sun-damaged skin on the patients forearm, Squamous cell carcinomas (SCCs), peri-lesional skin to SCCs and actinic keratoses (AKs). The swabbing technique has been tested in previous pilot studies and involves using sterile swabs moistened in saline, to rub over the surface of the lesion/skin. Swabs are then stored in tubes for later DNA extraction and culturing.

All suspected SCCs will be recommended for routine excision and histology. We will request a copy of the subsequent pathology report to confirm SCC diagnosis. The member of the study team will also record information on demographic, and relevant medical history from the patient, as listed below. Clinical non-identifiable photographs of patient’s forearms and any SCCs will be taken.
Intervention code [1] 295115 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298722 0
Primary outcome is the identification of microbial communities present on different lesions of the skin. Microbiome identification will be performed by extracting DNA from swabs collected of patient lesions, then sequenced using standard laboratory procedures.
Timepoint [1] 298722 0
baseline - after swab collection.
Secondary outcome [1] 325053 0
To support the primary outcome, we will also seek to identify microbiome from swabs using bacterial and yeast/fungi culture and isolation techniques.
Timepoint [1] 325053 0
baseline - after swab collection.

Eligibility
Key inclusion criteria
All participants in the study will need to have been immune-suppressed for over 1 year as a result of a kidney or liver transplant, prior to enrolling in the study. They will also need to be over the age of 40 years old. Participants are divided into three specific groups based on whether they have current SCCs (anywhere on the body) or AKs (on either forearm).
There will be 3 distinct groups recruited;
1. Renal/liver transplant recipients with over 1 year of immune-suppression, with no AKs
2. Renal/liver transplant recipients with over 1 year of immune-suppression, with at least 2 AKs on one forearm.
3. Renal/liver transplant recipients with over 1 year of immune-suppression, with one SCC located anywhere on the body.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Topical medicated creams to the area being sampled i.e. 5-fluorouracil, imiquimod, diclofenac sodium, ingenol mebutate, PDT, corticosteroid. Topical keratolytics.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Once DNA is extracted, amplified and sequenced, then bioinformatics and biostatistical analysis will be able to identify any microbial populations associated with squamous cell carcinoma, actinic keratosis and sun-damaged skin.

This is an exploratory observational study, no formal sample size calculation was performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6012 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 13437 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 293898 0
Government body
Name [1] 293898 0
National Health and Medical Research Council (NHMRC)
Address [1] 293898 0
GPO Box 1421
Canberra ACT 2601
Country [1] 293898 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
TRI, 37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 292723 0
None
Name [1] 292723 0
Address [1] 292723 0
Country [1] 292723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295314 0
Metro South Health HREC
Ethics committee address [1] 295314 0
TRI, Level 7, 37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 295314 0
Australia
Date submitted for ethics approval [1] 295314 0
18/05/2016
Approval date [1] 295314 0
23/06/2016
Ethics approval number [1] 295314 0
HREC/16/QPAH/364

Summary
Brief summary
We have conducted pilot research in the significance of skin microorganisms in the conversion of AK to squamous cell carcinoma (SCC) in healthy volunteers and wish to compare these data to transplant recipients. Transplant patients, who are required to take immune-supressing drugs, are at a much higher risk of skin cancers than people in the general population. There is a necessity to study the relevance of the skin microbiome in transplant recipients as they are more vulnerable to the conversion of AK to SCC. We seek to compare the microbiome of transplant patients who have been immune-supressed for over 1 year, who have no AKs, many AKs, and those with suspected SCCs. The microbiome will be examined by taking skin swabs from participants and analysed by DNA extraction and microbe culture and isolation. In the case of suspected SCCs, patients will undergo routine care for their recommended removal, and the study team will request a copy of the subsequent pathology report to confirm SCC diagnosis.

Who is it for? All participants in the study will need to have been immune-suppressed for over 1 year as a result of a kidney or liver transplant, prior to enrolling in the study. They will also need to be over the age of 40 years old. Participants are divided into three specific groups based on whether they have current SCCs (anywhere on the body) or AKs (on either forearm).

Study details: Participants will be recruited during their routine follow up visits with the renal/liver transplant services at Princess Alexandra Hospital. If they consent to take part in the study, the study visit can occur after their follow up visit, or scheduled for a later date. Swabs will be taken from standardised control sites of sun-damaged skin on the patients forearm, SCCs, peri-lesional skin to SCCs and AKs. The swabbing technique has been tested in previous pilot studies. All suspected SCCs will be recommended for routine excision and histology. We will request a copy of the subsequent pathology report to confirm SCC diagnosis. The member of the study team will also record information on demographic, and relevant medical history from the patient. Clinical non-identifiable photographs of patient’s forearms and any SCCs will be taken.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 66842 0
Prof H. Peter Soyer
Address 66842 0
Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102
Country 66842 0
Australia
Phone 66842 0
+61 7 3443 8017
Fax 66842 0
+61 7 3443 7779
Email 66842 0
p.soyer@uq.edu.au
Contact person for public queries
Name 66843 0
Mrs Clare Primiero
Address 66843 0
Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102
Country 66843 0
Australia
Phone 66843 0
+61 7 3443 7496
Fax 66843 0
+61 7 3443 7779
Email 66843 0
c.bover@uq.edu.au
Contact person for scientific queries
Name 66844 0
Mrs Clare Primiero
Address 66844 0
Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102
Country 66844 0
Australia
Phone 66844 0
+61 7 3443 7496
Fax 66844 0
+61 7 3443 7779
Email 66844 0
c.bover@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary