In Vivo Real-time Detection of Circulating Melanoma Cells

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by University of Arkansas

Sponsor:

Information provided by (Responsible Party):

University of Arkansas

ClinicalTrials.gov Identifier:

NCT01776905

First received: January 14, 2013

Last updated: August 26, 2016

Last verified: August 2016

History of Changes

Purpose

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
Melanoma


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	In Vivo Real-time Detection of Circulating Melanoma Cells

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Number of participants that possess circulating tumor cells. [ Time Frame: 14-21 days ] [ Designated as safety issue: No ]


Estimated Enrollment:	75
Study Start Date:	February 2013
Estimated Study Completion Date:	August 2017
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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:

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.
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.
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


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776905

Contacts


Contact: Laura Hutchins, MD	501-686-8530	HutchinsLauraF@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: Laura Hutchins, MD
Sub-Investigator: Vladimir Zharov, PhD
Sub-Investigator: Ekaterina Galanzha, PhD
Sub-Investigator: Sara Shalin, MD

Sponsors and Collaborators

University of Arkansas

Investigators


Principal Investigator:	Laura Hutchins, MD	University of Arkansas

More Information


Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT01776905 History of Changes
Other Study ID Numbers:	133965
Study First Received:	January 14, 2013
Last Updated:	August 26, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016

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