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In Vivo Liquid Biopsy of Melanoma (Cytophone)

Cytoastra · NCT06488365

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
180
US sites recruiting
1
Study start
February 11, 2025
Record last updated
March 11, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Cytophone

Conditions: Melanoma; Circulating Tumor Cells; Metastatic Melanoma; Diagnosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • SSM Health Dean Medical Group Specialty Services

    Madison, WI 53715

    Site contact: Lisa Lepeak, MD

Study contacts (from the official record)

  • James Golleher, MBA · 5017658175 · jgolleher@cytoastra.com
All healthy volunteers studies in Wisconsin →
In Vivo Liquid Biopsy of Melanoma (Cytophone) (NCT06488365) | Bored Studies