In Vivo Real-time Detection of Circulating Melanoma Cells
This study is not yet open for participant recruitment.
Verified January 2013 by University of Arkansas
Sponsor:
University of Arkansas
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01776905
First received: January 14, 2013
Last updated: January 23, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 Primary Completion Date: | January 2014 (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 |
| 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
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 | Not yet 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
No publications provided
| 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: | January 23, 2013 |
| 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 May 23, 2013