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To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.
Cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctDNA. Circulating tumor DNA (ctDNA) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctDNA. Participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctDNA) and more quickly be switched to more effective therapies. Further, the treating physician could hold therapy until the first signs of ctDNA based recurrence for those participants that would benefit.
Blood sample from a biobank will be used to identify to monitor ctDNA. These blood samples were drawn at baseline, 3 months, 6 months and 18 months.
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| Measure | Description | Time Frame |
|---|---|---|
| Identify a pattern for gene recognition of cancer recurrence earlier than standard of care. | Genomic sequencing of 40+ ctDNA genes will be analyzed to identify genetic alterations correlating with the development of recurrence in melanoma. | samples taken at baseline, 3 months, 6 months and 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze the genetic pathway associated with cancer recurrence and biologic information. | The sequencing data will be analyzed against established determinants of cancer biology in clinically relevant melanoma variants identified via analysis of The Cancer Genome Atlas database. | samples taken at baseline, 3 months, 6 months and 18 months. |
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Inclusion Criteria:
Exclusion Criteria:
• Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design
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Retrospective biobanking samples collected at baseline, 3 months, 6 months and 18 months.
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| Name | Affiliation | Role |
|---|---|---|
| James Isaacs, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer center | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Retrospectively collected blood samples from a biobank.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |