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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002374-07 | U.S. NIH Grant/Contract | View source | |
| UW24066 | Other Identifier | UW Madison | |
| A534260 | Other Identifier | UW Madison | |
| Protocol Version 9/9/24 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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:
Participants undergoing regular treatment for their skin cancer will provide blood samples.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin cancer | Participants with melanoma or non-melanoma skin cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw for the laboratory assessment | Other | Participants will have 50 milliliters (3.5 tablespoons) of blood drawn |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be from the Melanoma Medical Oncology Clinic at the Carbone Cancer Center.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Ma, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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Blood
| 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 |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D008545 | Melanoma |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018295 | Neoplasms, Basal Cell |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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