Using blood markers to differentiate between benign and malignant lung nodules
Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
This study is testing if a blood marker can help tell the difference between harmless and cancerous lung nodules in patients who have had surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 15 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Cancer Hospital & Institute of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06531850 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the potential of the serum marker LncRNA RP5-977B1 in distinguishing between benign and malignant pulmonary nodules identified through imaging. It will involve collecting leftover blood samples from patients who have undergone surgery for pulmonary nodules, with a focus on constructing diagnostic models that combine this marker with clinical protein tumor markers. The study will assess the sensitivity and specificity of these markers based on pathological results, providing new insights into the diagnosis of lung tumors.
Who should consider this trial
Good fit: Ideal candidates are patients aged 15-75 with pulmonary nodules detected by imaging who are scheduled for surgical resection.
Not a fit: Patients with a history of malignant tumors or serious underlying diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for patients with pulmonary nodules, potentially reducing unnecessary surgeries.
How similar studies have performed: While the approach of using serum markers for diagnosis is established, the specific use of LncRNA RP5-977B1 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Pulmonary nodules were detected by imaging and surgically resected.
* Age 15-75 years old.
* Surgery or puncture is to be performed for pathological diagnosis.
* Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked.
Exclusion Criteria:
* Patient samples have hemolysis, have been contaminated, have been placed for too long, have insufficient sample allowance, and record mixed samples.
* History of malignant tumor. ③ Serious underlying diseases and complications may affect systemic treatment. ④ Can not guarantee to receive blood tests on time. ⑤ Received anti-tumor Chinese medicine, immunization, chemotherapy and other treatments within 2 weeks.
Where this trial is running
Guangzhou, Guangdong
- Cancer Hospital & Affiliated Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zijian Wu, Learned
- Email: 463596459@qq.com
- Phone: 020-66673666
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.