Lung CancerNCT06261294
OncoSweep Cancer Spotlight and Spectrum Product Line
An observational study of Lung Cancer, run by Pharus Taiwan, Inc. at 1 site in Taiwan.
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' Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- OncoSweep Lung Spotligh
- How many people
- 109 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 May 2023to 7 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form.
- Individual is aged 18 years old or above.
- 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.
- 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%).
- Individual did not donate blood or receive blood transfusion within two months before joining the study.
Who cannot join
- Individual who is not suitable for participating as per Investigator's judgement.
- Individual who has undergone gene therapy or related product within one year prior to enrolling in this study.
- Individual who is attending another clinical study at the time of enrollment.
- Individual who is known to be pregnant.
- Individual who has received a vaccine within two weeks.
- Individual who has a history of any cancer occurrences other than lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
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
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'
Read the 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
- Being tested
- OncoSweep Lung Spotligh
- Keywords
- cancer study
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoSweep Lung SpotlighDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: OncoSweep Lung Spotligh |
What is being measured
The primary outcome is the main question the study is designed to answer.
To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight.
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start29 May 2023
- Primary completion3 Mar 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharus Taiwan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261294
- Sponsor's protocol ID
- CPIP-LUN-A001
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06261294
- Acronym / sponsor ID
- CPIP-LUN-A001
- Conditions
- Lung Cancer
- Keywords
- cancer study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Pharus Taiwan, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two group Study arm determination based | – | Diagnostic Test: OncoSweep Lung SpotlighSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoSweep Lung SpotlighThis 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. | Diagnostic test | two group Study arm determination based |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Pharus Taiwan, Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.