In Vivo Real-time Detection of Circulating Melanoma Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.
Detailed description
Study Population: Approximately 80 subjects will be consented in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts as follows:
1. Cohort #1 will consist of fifteen healthy control subjects, ten of whom will be Caucasian and five of whom will be African-American. Subjects in cohort #1 will be used to address the calibration goal of Specific Aim #1. 2. Cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be recruited from the Medical Oncology clinic at UAMS, where advanced stages are defined as Stages III or IV. Subjects in cohort #2 will be used to address the validation goal of Specific Aim #2. Approximately half of the 30 advanced-stage subjects will be Stage III and the other half will be Stage IV. 3. Cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from the Surgical Oncology clinic at UAMS, where early stages are defined as Stages I or II.
Subjects in cohort #3 will be used to address the detection goal of Specific Aim #3. Approximately 10 of the 30 early-stage subjects will be Stage I and approximately 20 will be Stage II.
Primary outcome measures
- Number of participants that possess circulating tumor cells. [Time frame: 14-21 days]
Eligibility criteria
Inclusion criteria
- Age 18 to 80 years
- Histological documented diagnosis of melanoma
- Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)
- Must be able to sit still for 90 minutes
Exclusion criteria
- Active infection
- Current and significant medical or surgical condition as determined by the Investigator
- Diagnosis or evidence of organic brain syndrome
- Pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- University of Arkansas for Medical Sciences — Little Rock
Identifiers
NCT: NCT01776905 · 133965