Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers

NCT06608511 | Recruiting DMC

• 5 other identifiers: 2024-1143KL2TR002374-07UW24066A534260Protocol Version 9/9/24
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• 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.

  Baseline to progression, up to 3 years

• 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.

  Baseline to progression, up to 3 years

• 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

  Baseline to progression, up to 3 years

• 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.

  Baseline to progression, up to 3 years

• 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.

  Baseline to progression, up to 3 years

• 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

  Baseline to progression, up to 3 years

• 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

  Baseline to progression, up to 3 years

• 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

  Baseline to progression, up to 3 years

• 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

  Baseline to progression, up to 3 years

Study Arms (1)

Skin cancer

Participants with melanoma or non-melanoma skin cancer

Other: Blood draw for the laboratory assessment

Interventions

Blood draw for the laboratory assessment OTHER

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

Skin cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Skin Neoplasms; Melanoma; Carcinoma, Basal Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vincent Ma, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Kim Mast

CONTACT

608-263-8606; mast2@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)