OncoSweep Cancer Spotlight & Spectrum Product Line

Status Recruiting

Clinical Trial 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'

Clinical Trial 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 Design

Related Conditions & MeSH terms

Lung Cancer

Clinical Trial Details

NCT number	NCT06261294
Study type	Observational
Source	Pharus Taiwan, Inc.
Contact	Sheng-Hsiung Yang
Phone	(02) 2543-3535
Email	lazatemax@gmail.com
Status	Recruiting
Phase
Start date	May 23, 2023
Completion date	March 20, 2026

View Details

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