A new method to detect melanoma cells in blood without surgery
In Vivo Liquid Biopsy for Early Detection of Metastatic Melanoma
This study is testing a new blood test called the Cytophone to see if it can safely find melanoma cells in patients without needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cytoastra Industry-sponsored |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06488365 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Cytophone, a patented system designed to identify and count circulating melanoma cells in the bloodstream. By analyzing a significantly larger volume of blood than traditional tests, the Cytophone aims to detect these rare cells non-invasively, without the need for injections or incisions. The study seeks to establish a correlation between circulating tumor cell counts and the risk of melanoma metastasis, recurrence, and treatment efficacy, potentially allowing for earlier intervention in patients. The trial will involve patients with a confirmed diagnosis of melanoma who can provide informed consent and sit for the procedure.
Who should consider this trial
Good fit: Ideal candidates are individuals with a histologically confirmed diagnosis of melanoma who can provide informed consent.
Not a fit: Patients with significant systemic diseases or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could enable earlier detection of melanoma metastasis, improving patient outcomes through timely intervention.
How similar studies have performed: While the approach of using circulating tumor cells for early detection is gaining traction, the specific use of the Cytophone device represents a novel application in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological documented diagnosis of melanoma; * Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks; * Must be able to sit for up to 60 minutes. Exclusion Criteria: * Unable to provide informed consent to participate in the study, such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study; * Clinically relevant cardiovascular, hepatic, neurological (e.g., evidence of organic brain syndrome), endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study; * Persistent significant or severe infection, either acute or chronic; * Pregnant or breast-feeding women or those who plan to become pregnant during the study; * Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy; * Any known history of severe preexisting constipation.
Where this trial is running
Madison, Wisconsin
- SSM Health Dean Medical Group Specialty Services — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: James Golleher, MBA
- Email: jgolleher@cytoastra.com
- Phone: 5017658175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.