Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-08 @ 4:48 AM
Study NCT ID:
NCT06261294
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2024-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OncoSweep Cancer Spotlight and Spectrum Product Line
Sponsor:
Pharus Taiwan, Inc.
Organization:
Study Overview
Official Title:
CONQUER Cancer Study: To Collect Blood Samples From Cancer and Non-cancer Participants for Development and Validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief Summary:
CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line'
Detailed Description:
OncoSweep Cancer Spotlight and Spectrum Product Lines are qualitative in vitro diagnostic devices testing plasma specimens for detecting circulating miRNA expression, ctDNA methylation status, platelet RNA analysis, and tumor marker expressions by utilizing real-time polymerase chain reaction (qPCR) and next-generation sequencing (NGS). This is a two-arm, open-label, non-randomized controlled pilot study intends to screen adults 18 years or older, who are treatment-naïve for cancers and have pulmonary nodules or mass detected by low-dose computerized tomography (LDCT) or standard computerized tomography (CT) scans. OncoSweep Lung Spotlight will be utilized with venous blood samples collected in the healthcare facility where the study is being conducted. The X-ray, LDCT/ standard CT scan, blood laboratory test data, or biopsy results will be collected from the control group, and the blood sample will be analyzed by OncoSweep Lung Spotlight. Results generated from both groups will be evaluated against each other. The result of OncoSweep Lung Spotlight provides additional evidence to support or assist medical diagnoses when used in combination with LDCT/ standard CT scan data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: