Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488365
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-28
Brief Title:
In Vivo Liquid Biopsy of Melanoma Cytophone
Sponsor:
Cytoastra
Organization:
Cytoastra
Study Overview
Official Title:
In Vivo Liquid Biopsy for Early Detection of Metastatic Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cytophone
Brief Summary:
The Cytophone is a first in the world patented system to identify and count single circulating melanoma cells in blood circulation inside the human body The Cytophone has a unique capability to find rare melanoma cells in the blood by an assessment of 100-500 times greater amounts of blood volume than routine blood tests The important benefit of the Cytophone diagnosis is that the test does not require injection or any skin incision ie non-invasiveness The goal of this clinical trial is to demonstrate evidence of the capability of the Cytophone test to indicate a risk of metastasis and define CTC counts that correlate with melanoma recurrence progression of metastatic disease and therapy efficacy The investigators believe that clinical trials will provide evidence that the Cytophone can diagnose risk of melanoma metastasis and recurrence earlier than existing methods
Detailed Description:
The majority of melanoma deaths are associated with metastasis that are formed by cancer cells shedding from the primary tumor that enter the circulation and spread to distant organs via blood circulation These cells in blood are referred to as circulating tumor cells CTCs Growing evidence suggests that metastasis is an early event in melanoma patients often occurring before metastases are clinically detectable Therefore detection of CTCs using liquid biopsy assays should be considered as an effective tool to diagnose early the risk of metastasis progression Taking into account the link of CTCs with metastasis CTCs have an advantage over many other biomarkers in identifying patients for early therapeutic intervention at a stage when the disease is still manageable and possibly curable Overall CTCs are in the blood circulation in early stage disease yet they are typically detected in later stage disease Currently the main issue restricting the use of CTCs for early melanoma detection relates to the low sensitivity of existing assays due to assessment of limited blood volume ie blood samples in vitro To maximize the blood volume available for analysis in vivo CTC enumeration without labelling in a large blood volume using the Cytophone device was developed by our team The Cytophone represents a photoacoustic PA flow cytometry PAFC diagnostic platform Our feasibility clinical study has demonstrated the detection of CTCs in 49 of 50 melanoma patients sensitivity 98 and in 0 of 18 in healthy subjects control group The investigators received clinical evidence of the Cytophones capability to diagnose 0006 CTCsmL which is significantly higher than sensitivity of existing testing methodologies
The Goal of this clinical study is to determine whether the Cytophone device can be used for in vivo detection and enumeration of CTCs in melanoma patients at different disease stages with a focus on early melanoma detection and prognosis It is expected that the detection limit of CTCs will be improved compared to the detection limits of existing methods
The investigators hypothesize that our CTC assay in vivo provides earlier rapid and more accurate diagnosis and prognosis of metastasis progression in melanoma patients To achieve our goal the investigators will accomplish the following primary and secondary objectives
The primary objectives
1 Obtain evidence that a positive Cytophone CTC test indicates a risk of metastasis development
2 Define thresholds of CTC counts that correlate with melanoma recurrence and progression of metastatic disease
The secondary objective
1 Determine if the Cytophone diagnoses the risk of melanoma metastasis progression and recurrence earlier than existing methods
The Goal of this clinical study is to determine whether the Cytophone device can be used for in vivo detection and enumeration of CTCs in melanoma patients at different disease stages with a focus on early melanoma detection and prognosis It is expected that the detection limit of CTCs will be improved compared to the detection limits of existing methods
The investigators hypothesize that our CTC assay in vivo provides earlier rapid and more accurate diagnosis and prognosis of metastasis progression in melanoma patients To achieve our goal the investigators will accomplish the following primary and secondary objectives
The primary objectives
1 Obtain evidence that a positive Cytophone CTC test indicates a risk of metastasis development
2 Define thresholds of CTC counts that correlate with melanoma recurrence and progression of metastatic disease
The secondary objective
1 Determine if the Cytophone diagnoses the risk of melanoma metastasis progression and recurrence earlier than existing methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None