Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers

May 28, 2026 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be from the Melanoma Medical Oncology Clinic at the Carbone Cancer Center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Skin cancer
Participants with melanoma or non-melanoma skin cancer
Other: Blood draw for the laboratory assessment
Participants will have 50 milliliters (3.5 tablespoons) of blood drawn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tumor-derived exosomes and progression free survival
Time Frame: 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.
Baseline to progression, up to 3 years
Change in circulating tumor cells and progression free survival
Time Frame: 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.
Baseline to progression, up to 3 years
Change in circulating tumor DNA and progression free survival
Time Frame: 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
Baseline to progression, up to 3 years
Change in tumor-derived exosomes and overall survival
Time Frame: 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.
Baseline to progression, up to 3 years
Change in circulating tumor cells and overall survival
Time Frame: 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.
Baseline to progression, up to 3 years
Change in circulating tumor DNA and overall survival
Time Frame: 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
Baseline to progression, up to 3 years
Change in tumor-derived exosomes and treatment response
Time Frame: 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
Baseline to progression, up to 3 years
Change in circulating tumor cells and treatment response
Time Frame: 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
Baseline to progression, up to 3 years
Change in circulating tumor DNA and treatment response
Time Frame: 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
Baseline to progression, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Vincent Ma, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1143
  • A534260 (Other Identifier: UW Madison)
  • KL2TR002374-07 (U.S. NIH Grant/Contract)
  • UW24066 (Other Identifier: UW Madison)
  • Protocol Version 9/9/24 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Cancer

Clinical Trials on Blood draw for the laboratory assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe