Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers

Recruiting

• Conditions: Merkel Cell Carcinoma of Skin; Skin Cancer; Melanoma (Skin Cancer); Basal Cell Carcinoma of Skin; Basal Cell Carcinoma of Skin, Site Unspecified; Cutaneous Squamous Cell Carcinoma (CSCC)
• Interventions: Other: Blood draw for the laboratory assessment

• Registration Number: NCT06608511
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The goal of this observational study is to study blood samples and compare them to other biospecimens and clinical outcomes in participants who have melanoma or non-melanoma skin cancers. The main question it aims to answer is:

* Are blood based signatures able to predict progression-free survival (PFS)?

Participants undergoing regular treatment for their skin cancer will provide blood samples.

Detailed Description

This observational study is being done to identify possible biomarkers that can be used for prognostic, prediction, or monitoring considerations in patients with melanoma or non-melanoma skin cancer undergoing treatment. Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood) and their associated protein and mRNA expression; circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood); and tumor-derived exosomes (i.e., extracellular vesicles generated by cancer cells that carry nucleic acids, proteins, and metabolites).

Study Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Study Start: 2024-12-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age ≥18 years.
• Participants must meet at least one of the following criteria:
• Finding suspicious of melanoma or non-melanoma skin cancer based on clinical, radiographic, or laboratory findings. Non-melanoma skin cancers include: basal cell carcinoma, cutaneous squamous cell carcinoma, and Merkel cell carcinoma.
• A confirmed diagnosis of melanoma or non-melanoma skin cancer.

Exclusion Criteria

• Vulnerable populations, including pregnant women, those who lack consent capacity, the mentally ill, prisoners, cognitively impaired persons, children (age <18), and UW employees that report to the investigator(s) or to study team members.
• Not suitable for study participation due to other reasons at the discretion of the investigators.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Skin cancer	Blood draw for the laboratory assessment	Participants with melanoma or non-melanoma skin cancer

Primary Outcome Measures

Name	Time	Method
Change in tumor-derived exosomes and progression free survival	Baseline to progression, up to 3 years	To investigate whether changes in tumor-derived exomes measured in serum could represent a potential prognostic biomarker, measured as progression free survival (the duration of time from Day 1 of treatment to time of progression based on clinical or radiographic grounds) or death as a results of any cause, whichever occurs first.
Change in circulating tumor cells and progression free survival	Baseline to progression, up to 3 years	To investigate whether changes in circulating tumor cells measured in serum could represent a potential prognostic biomarker, measured as progression free survival (PFS). PFS is the duration of time from Day 1 of treatment to time of progression (based on clinical or radiographic grounds) or death as a result of any cause, whichever occurs first.
Change in circulating tumor DNA and progression free survival	Baseline to progression, up to 3 years	To investigate whether changes in circulating tumor DNA measured in serum could represent a potential prognostic biomarker, measured as progression free survival. PFS is the duration of time from Day 1 of treatment to time of progression (based on clinical or radiographic grounds) or death as a result of any cause, whichever occurs first
Change in tumor-derived exosomes and overall survival	Baseline to progression, up to 3 years	To investigate whether changes in tumor-derived exomes measured in serum could represent a potential prognostic biomarker measured as overall survival (OS). OS - the duration of time from Day 1 of treatment to time of death as a result of any cause.
Change in circulating tumor cells and overall survival	Baseline to progression, up to 3 years	To investigate whether changes in circulating tumor cells measured in serum could represent a potential prognostic biomarker measured as overall survival. OS - the duration of time from Day 1 of treatment to time of death as a result of any cause.
Change in circulating tumor DNA and overall survival	Baseline to progression, up to 3 years	To investigate whether changes in circulating tumor DNA measured in serum could represent a potential prognostic biomarker measured as overall survival. OS - the duration of time from Day 1 of treatment to time of death as a result of any cause
Change in tumor-derived exosomes and treatment response	Baseline to progression, up to 3 years	To investigate whether changes in tumor-derived exomes measured in serum could represent a potential prognostic biomarker measured as treatment response. Treatment response - rate of objective response (partial response + complete response) and disease control rate (stable disease + partial response + complete response) per RECIST v1.1
Change in circulating tumor cells and treatment response	Baseline to progression, up to 3 years	To investigate whether changes in circulating tumor cells measured in serum could represent a potential prognostic biomarker measured as response to treatment. Treatment response - rate of objective response (partial response + complete response) and disease control rate (stable disease + partial response + complete response) per RECIST v1.1
Change in circulating tumor DNA and treatment response	Baseline to progression, up to 3 years	To investigate whether changes in circulating tumor DNA measured in serum could represent a potential prognostic biomarker measured as response to treatment. Treatment response - rate of objective response (partial response + complete response) and disease control rate (stable disease + partial response + complete response) per RECIST v1.1

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States