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
Conditions
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).
Interventions
Participants will have 50 milliliters (3.5 tablespoons) of blood drawn
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tumor-derived exosomes and progression free survival | 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. |
| Change in circulating tumor cells and progression free survival | 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. |
| Change in circulating tumor DNA and progression free survival | 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 |
| Change in tumor-derived exosomes and overall survival | 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. |
| Change in circulating tumor cells and overall survival | 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. |
| Change in circulating tumor DNA and overall survival | 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 |
| Change in tumor-derived exosomes and treatment response | 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 |
| Change in circulating tumor cells and treatment response | 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 |
| Change in circulating tumor DNA and treatment response | 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 |
Countries
United States
Contacts
Primary ContactCancer Connect
Backup ContactKim Mast
Outcome results
None listed