In Vivo Liquid Biopsy of Melanoma (Cytophone) (NCT06488365)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: SSM Health Dean Medical Group Specialty Services — Madison, Wisconsin
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- SSM Health Dean Medical Group Specialty Services — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.