Actinic Keratosis and Squamous Cell Carcinoma Cross-sectional Microbiome study in Transplant Recipients

Not Applicable

Completed

• Conditions: Squamous Cell Carcinoma; Actinic Keratosis; Skin - Dermatological conditions; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12616000876493
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[baseline - after swab collection.]

Secondary Outcome Measures

Name	Time	Method
To support the primary outcome, we will also seek to identify microbiome from swabs using bacterial and yeast/fungi culture and isolation techniques.[baseline - after swab collection.]