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Active, not recruitingNCT06608511Updated May 29, 2026

Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers

An observational study in Skin Cancer, Melanoma (Skin Cancer) and Basal Cell Carcinoma of Skin, sponsored by University of Wisconsin, Madison. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by University of Wisconsin, Madison · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Skin Cancer
  • Melanoma (Skin Cancer)
  • Basal Cell Carcinoma of Skin
  • Basal Cell Carcinoma of Skin, Site Unspecified
  • Cutaneous Squamous Cell Carcinoma (CSCC)
  • Merkel Cell Carcinoma of Skin
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In context

Skin Neoplasms

582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 134 observational studies indexed under Skin Neoplasms.

Browse Skin Neoplasms studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Skin cancer

    Participants with melanoma or non-melanoma skin cancer

    Other: Blood draw for the laboratory assessment

Interventions

  • OtherBlood draw for the laboratory assessment

    Participants will have 50 milliliters (3.5 tablespoons) of blood drawn

06

What researchers measure

Primary outcomes

  1. Change in tumor-derived exosomes and progression free survival

    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.

    Time frame: Baseline to progression, up to 3 years

  2. Change in circulating tumor cells and progression free survival

    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.

    Time frame: Baseline to progression, up to 3 years

  3. Change in circulating tumor DNA and progression free survival

    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

    Time frame: Baseline to progression, up to 3 years

  4. Change in tumor-derived exosomes and overall survival

    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.

    Time frame: Baseline to progression, up to 3 years

  5. Change in circulating tumor cells and overall survival

    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.

    Time frame: Baseline to progression, up to 3 years

  6. Change in circulating tumor DNA and overall survival

    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

    Time frame: Baseline to progression, up to 3 years

  7. Change in tumor-derived exosomes and treatment response

    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

    Time frame: Baseline to progression, up to 3 years

  8. Change in circulating tumor cells and treatment response

    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

    Time frame: Baseline to progression, up to 3 years

  9. Change in circulating tumor DNA and treatment response

    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

    Time frame: Baseline to progression, up to 3 years

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Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06608511
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Dec 11, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 29, 2026

Study contacts

Vincent Ma, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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