Blood sample collection for lung cancer detection
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
This study is testing whether blood samples can help find lung cancer earlier by comparing the results with imaging tests in adults who have suspicious lung nodules or masses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pharus Taiwan, Inc. Industry-sponsored |
| Locations | 1 site (Taipei, Zhongshan Dist) |
| Trial ID | NCT06261294 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples from individuals with and without lung cancer to develop and validate the OncoSweep Cancer Spotlight and Spectrum Product Line. It utilizes advanced diagnostic techniques such as qPCR and next-generation sequencing to analyze plasma specimens for various cancer biomarkers. Participants aged 18 and older, who are treatment-naïve and have pulmonary nodules or masses detected by imaging, will be screened. The study compares results from blood samples with data from imaging tests to enhance diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pulmonary nodules or masses detected by CT scans who have not yet received treatment.
Not a fit: Patients who have already undergone treatment for lung cancer or have abnormal findings from imaging tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the early detection and diagnosis of lung cancer, leading to better patient outcomes.
How similar studies have performed: Other studies utilizing similar diagnostic approaches have shown promise in improving cancer detection, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taipei, Zhongshan Dist
- Mackay Memorial Hospital — Taipei, Zhongshan Dist, Taiwan (Recruiting)
Study contacts
- Study coordinator: Sheng-Hsiung Yang
- Email: lazatemax@gmail.com
- Phone: (02) 2543-3535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.