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Active, Not Recruiting

NCT Number: NCT06608511

Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Skin Cancer Basal Cell Carcinoma of Skin Basal Cell Carcinoma of Skin, Site Unspecified Carcinoma Carcinoma, Basal Cell Cutaneous Squamous Cell Carcinoma (CSCC) Melanoma Melanoma (Skin Cancer) Merkel Cell Carcinoma of Skin Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draw for the laboratory assessment

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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