NCT06488365Recruiting
In Vivo Liquid Biopsy of Melanoma (Cytophone)
In Vivo Liquid Biopsy for Early Detection of Metastatic Melanoma
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 28 Jun 2024
- Start date
- 11 Feb 2025
- Primary completion date
- 11 Feb 2026
- Lead sponsor
- Cytoastra
- Diseases
- Melanoma
- NCT number
- NCT06488365
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 11 Feb 2025 to the primary completion date, 11 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Any known history of severe preexisting constipation.
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SSM Health Dean Medical Group Specialty Services Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.