Clinical trial NCT06608511: Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers
Official title: Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be from the Melanoma Medical Oncology Clinic at the Carbone Cancer Center.

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).

Eligibility criteria: 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 \&amp;lt;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.

Primary outcomes:
measure: Change in tumor-derived exosomes and progression free survival
timeFrame: Baseline to progression, up to 3 years
measure: Change in circulating tumor cells and progression free survival
timeFrame: Baseline to progression, up to 3 years
measure: Change in circulating tumor DNA and progression free survival
timeFrame: Baseline to progression, up to 3 years
measure: Change in tumor-derived exosomes and overall survival
timeFrame: Baseline to progression, up to 3 years
measure: Change in circulating tumor cells and overall survival
timeFrame: Baseline to progression, up to 3 years
measure: Change in circulating tumor DNA and overall survival
timeFrame: Baseline to progression, up to 3 years
measure: Change in tumor-derived exosomes and treatment response
timeFrame: Baseline to progression, up to 3 years
measure: Change in circulating tumor cells and treatment response
timeFrame: Baseline to progression, up to 3 years
measure: Change in circulating tumor DNA and treatment response
timeFrame: Baseline to progression, up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Vincent Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: