NCT06488365 In Vivo Liquid Biopsy of Melanoma (Cytophone)
| NCT ID | NCT06488365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cytoastra |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2026-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-02-11 with a primary completion date of 2026-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Cytophone is a first in the world patented system to identify and count single circulating melanoma cells in blood circulation inside the human body. The Cytophone has a unique capability to find rare melanoma cells in the blood by an assessment of 100-500 times greater amounts of blood volume than routine blood tests. The important benefit of the Cytophone diagnosis is that the test does not require injection or any skin incision (i.e., non-invasiveness). The goal of this clinical trial is to demonstrate evidence of the capability of the Cytophone test to indicate a risk of metastasis and define CTC counts that correlate with melanoma recurrence, progression of metastatic disease, and therapy efficacy. The investigators believe that clinical trials will provide evidence that the Cytophone can diagnose risk of melanoma metastasis and recurrence earlier than existing methods.
Eligibility 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.
Contact & Investigator
Ekaterina Galanzha, PhD
STUDY DIRECTOR
Cytoastra
Frequently Asked Questions
Who can join the NCT06488365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06488365 currently recruiting?
Yes, NCT06488365 is actively recruiting participants. Contact the research team at jgolleher@cytoastra.com for enrollment information.
Where is the NCT06488365 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06488365 clinical trial?
NCT06488365 is sponsored by Cytoastra. The principal investigator is Ekaterina Galanzha, PhD at Cytoastra. The trial plans to enroll 180 participants.
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