Autoantibody Biomarkers for Melanoma Detection.

Not Applicable

Recruiting

• Conditions: Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12619001044112
• Lead Sponsor: Edith Cowan university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-23
• Last Update Posted: 21 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Subject Population
The study population will be drawn from WAKMAS, private and public practices and hospitals. The patients will provide a blood sample prior to the time of biopsy for an early stage cutaneous melanoma.

Inclusion Criteria:
•Participants who have an abnormal skin lesion thought to be melanoma or other non-melanoma skin cancers or participants who have recently been diagnosed with other types of primary cancer or an autoimmune disease
•>18 years
•Written informed consent
•Willing and able to comply with study blood collection protocol
•Willing to provide relevant biopsy pathology report

Exclusion Criteria

Exclusion Criteria:
•People previously diagnosed with metastatic melanoma (TNM stage III and IV)
•Previously diagnosed with other cancers (excluding skin cancers)
•Surgical procedure in the last three months
•Previously diagnosed with an autoimmune disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the diagnostic accuracy of a combination of autoantibodies as assessed by comparison of the MelDx blood test to gold standard skin biopsy for early melanoma detection.<br><br>[Participant blood is collected prior to the collection of the biopsy of a suspicious lesion. Every participant will provide a blood sample only once. <br>Sample collection will continue until a sufficient number of samples has been collected (at least 100 confirmed melanoma cases are required which may necessitate the collection of approx. 1000 samples). Once all samples have been collected, these will be tested against the MelDx blood test and the results will reveal the overall diagnostic accuracy of the test relative to the standard biopsy. ]