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Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers

NCT ID: NCT06608511

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-11

Study Completion Date

2026-12-31

Brief Summary

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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

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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).

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Skin cancer

Participants with melanoma or non-melanoma skin cancer

Blood draw for the laboratory assessment

Intervention Type OTHER

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

Interventions

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Blood draw for the laboratory assessment

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Ma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cancer Connect

Role: CONTACT

[email protected]
800-622-8922

Kim Mast

Role: CONTACT

[email protected]
608-263-8606

Facility Contacts

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Cancer Connect

Role: primary

[email protected]
800-622-8922

Other Identifiers

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KL2TR002374-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UW24066

Identifier Type: OTHER

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 9/9/24

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1143

Identifier Type: -

Identifier Source: org_study_id