NCT06261294

OncoSweep Cancer Spotlight and Spectrum Product Line

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
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Pharus Taiwan, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OncoSweep Lung Spotligh	This study is to develop and validate the performance of OncoSweep Lung Spotlight for detecting circulating miRNA expression, ctDNA methylation status, platelet RNA, and tumor marker expressions by utilizing real-time polymerase chain reaction (qPCR). The method is to collect venous blood from subjects during their routine visit to the healthcare facilities.

Timeline

• Start date: 2023-05-29
• Primary completion: 2025-03-03
• Completion: 2025-05-07
• First posted: 2024-02-15
• Last updated: 2025-09-17

Locations

1 site across 1 country: Taiwan