ANZCTR - Registration

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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]

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

Actinic Keratosis

Condition category

Condition code

Skin

Dermatological conditions

Cancer

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]

Early Detection / Screening

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

baseline - after swab collection.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2016

Actual

9/09/2016

Date of last participant enrolment

Anticipated

1/08/2017

Actual

2/11/2017

Date of last data collection

Anticipated

Actual

2/11/2017

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

TRI, 37 Kent Street
Woolloongabba QLD 4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health HREC

Ethics committee address [1]

TRI, Level 7, 37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/05/2016

Approval date [1]

23/06/2016

Ethics approval number [1]

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

Prof H. Peter Soyer

Address

Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3443 8017

Fax

+61 7 3443 7779

p.soyer@uq.edu.au

Contact person for public queries

Name

Clare Primiero

Address

Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3443 7496

Fax

+61 7 3443 7779

c.bover@uq.edu.au

Contact person for scientific queries

Name

Clare Primiero

Address

Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3443 7496

Fax

+61 7 3443 7779

c.bover@uq.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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