atural history and properties of naevi in advanced melanoma patients receiving treatment

Not Applicable

Active, not recruiting

• Conditions: Melanoma; Skin - Other skin conditions; Cancer - Malignant melanoma; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12616000272493
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Cohort 1: melanoma patients with stage III and IV enrolled for treatment with targeted therapies and/or immunotherapies at the Cancer Services (PA Hospital). Baseline visit must be within 6 weeks of beginning melanoma treatment.

Cohort 2: participants considered high risk for melanoma under at least one of the following three subcategories;
a)Personal history of melanoma (stage I-IV, not in situ)
b)First degree family history of melanoma (stage I-IV, not in situ)
c)Atypical mole syndrome, defined as grater then 100 naevi, 6 (or more) atypical naevi (confirmed using dermoscopy), AND at least 1 naevus 8 mm (or greater) in dimension.

Exclusion Criteria

All participants must be able to give informed consent.

All participants are asked to commit to 4 visits to the PA Hospital to participate in the trial over a 12 month period (months 0, 4, 8 and 12), as long as they are able to (Participants can withdraw from the study at any time for any reason).

Participants in cohort 2 must not be currently undergoing any treatment for melanoma.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in somatic genotype/RNA expression profile of naevi that are characteristic of changeable naevi.<br><br>Analysis on somatic variations are possible by isolating DNA/RNA from individual naevi skin samples using either the microbiopsy or shave biopsy. [Every 4 months for 1 year];The primary outcome for the study is from the statistical analysis of the correlation of changing naevi pigmentation characteristics with genotyping and SNP typing of candidate genes in patients receiving treatment for advanced stage melanoma.<br><br>Naevi pigmentation characteristics are assessed using total body photography and individual dermoscopic images of naevi > 3mm. <br><br>Genotyping and SNP typing will be done by isolating DNA from saliva samples. <br>[every 4 months for 1 year.]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome for the study is from the statistical analysis of the correlation of changing naevi pigmentation characteristics with genotyping and SNP typing of candidate genes in a volunteer high risk cohort.<br><br>Naevi pigmentation characteristics are assessed using total body photography and individual dermoscopic images of naevi > 3mm. <br><br>Genotyping and SNP typing will be done by isolating DNA from saliva samples. [Every 4 months for 1 year]