OncoSweep Cancer Spotlight and Spectrum Product Line

September 10, 2025 updated by: Pharus Taiwan, Inc.

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

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'

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zhongshan Dist
      • Taipei, Zhongshan Dist, Taiwan, 104217
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This is a two-arm, open-label, non-randomized controlled pilot study intended to screen adults of 18 years or older, who are treatment-naïve for cancers, or who have pulmonary nodules or masses detected by LDCT or standard CT scan, utilizing OncoSweep Lung Spotlight with venous blood sample collected in the healthcare facility where the study is being conducted.

Description

Inclusion Criteria:

  • Inclusion

    1. Individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form.
    2. Individual is aged 18 years old or above.

    3. Individual who is willing to provide information on the given questionnaire. Test group: Individual was diagnosed with pulmonary nodules or masses by low-dose CT (LDCT)/ CT, and evaluated by the physician needed to conduct a biopsy or/ and surgery has been arranged.

      Control group: Individual is willing to undergo LDCT or CT scan with 3-5 mm spatial z-axis resolution, pulmonary function examination, X-ray, laboratory blood test, and blood drawing.

    4. Control group: Individual has no abnormal finding from LDCT or CT scan with 3-5 mm spatial z-axis resolution and pulmonary function examination(FEV1/FVC Ratio≧70%).
    5. Individual did not donate blood or receive blood transfusion within two months before joining the study.

Exclusion Criteria:

  • Exclusion

    1. Individual who is not suitable for participating as per Investigator's judgement.
    2. Individual who has undergone gene therapy or related product within one year prior to enrolling in this study.
    3. Individual who is attending another clinical study at the time of enrollment.
    4. Individual who is known to be pregnant.
    5. Individual who has received a vaccine within two weeks.
    6. Individual who has a history of any cancer occurrences other than lung cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
two group Study arm determination based

Subjects will be assigned into Test group or Control group based on the criteria:

  • Test group: Individual who has been diagnosed with lung nodule(s) or mass by his/ her healthcare provider utilizing LDCT or CT scan and has already scheduled for interventional procedure;
  • Control group: Individual is willing to undergo COPD examination and LDCT or CT scan with 3-5 mm spatial z-axis resolution and has no findings from the scan and examination
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight.
Time Frame: two years
To compare blood samples from lung cancer cases and non-cancer control subjects to develop and evaluate:1.Cancer models for discriminating lung cancer versus non-cancer 2.Platform evaluation 3.Data storage and algorithm establishment for further cancer research
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharus Taiwan, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Actual)

March 3, 2025

Study Completion (Actual)

May 7, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPIP-LUN-A001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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