In Vivo Real-time Detection of Circulating Melanoma Cells

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Melanoma

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	75 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	In Vivo Real-time Detection of Circulating Melanoma Cells
Study Start Date :	February 2013
Estimated Primary Completion Date :	August 2020
Estimated Study Completion Date :	August 2020

Groups and Cohorts

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Group/Cohort
Healthy control subjects; Characterize the baseline PA signals produced by the in vivo PAFC prototype device in healthy volunteers or Develop Standard Curves for the ex vivo CTC assays.
Advanced-Stage Melanoma; To validate the in vivo PAFC method of melanoma CTC detection, we will use the PAFC-based prototype device to noninvasively determine CTC concentrations in the blood of subjects who have advanced-stage (Stage III or Stage IV)melanoma, and we will also use current ex vivo methods to determine the CTC concentration in samples of blood drawn from the same subjects.
Early-Stage Melanoma; To determine whether in vivo PAFC can detect melanoma CTCs at concentrations below the detection limits of the ex vivo methods, we will use the PAFC-based prototype device to noninvasively detect CTCs in the blood of subjects who have early-stage (Stages I or II) melanoma, and we will also use current ex vivo methods to detect CTCs in samples of blood drawn from the same subjects.

Outcome Measures

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Primary Outcome Measures :

1. Number of participants that possess circulating tumor cells. [ Time Frame: 14-21 days ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Expect to consent approximately 80 subjects in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Issam Makhoul, MD	501-526-6990	MakhoulIssam@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Vladimir Zharov, PhD 501-603-1213 ZharovVladimirP@uams.edu
Principal Investigator: Fade Mahmoud
Sub-Investigator: Vladimir Zharov, PhD
Sub-Investigator: Ekaterina Galanzha, PhD
Sub-Investigator: Sara Shalin, MD

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:	Issam Makhoul, MD	University of Arkansas

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT01776905 History of Changes
Other Study ID Numbers:	133965
First Posted:	January 28, 2013
Last Update Posted:	March 29, 2018
Last Verified:	March 2018

Keywords provided by University of Arkansas:

Melanoma; Cancer

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas