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In Vivo Real-time Detection of Circulating Melanoma Cells

NCT01776905 · University of Arkansas
In plain English

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About this study
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.
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
Study design
Enrollment target: 75 participants
Age groups: adult, older_adult
Timeline
Starts: 2013-02
Estimated completion: 2026-07
Last updated: 2025-07-16
Primary outcomes
  • Number of participants that possess circulating tumor cells. (14-21 days)
Sponsor
University of Arkansas · other
Contacts & investigators
ContactJumin Sunde, MD · contact · Jsunde2@uams.edu · 501-526-6990
ContactDaniel Dunham · contact · ddunham@uams.edu · 5016868274
InvestigatorJumin Sunde, MD · principal_investigator, University of Arkansas
All locations (1)
University of Arkansas for Medical SciencesRecruiting
Little Rock, Arkansas, United States
In Vivo Real-time Detection of Circulating Melanoma Cells · TrialPath