Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Benign nodule
Study Overview
Brief Summary
Based on previous studies, this project intends to use prospective studies to select patients identified by imaging as pulmonary nodules to explore the potential of RP5-977B1 in differentiating benign and malignant pulmonary nodules, construct diagnostic models combined with clinical protein tumor markers, compare the diagnostic efficacy of the two, and finally determine the sensitivity and specificity of markers through pathological results. It provides a new content for the diagnosis of benign and malignant pulmonary nodules.
Detailed Description
For the purpose of clinical diagnosis, disease monitoring, treatment or prognosis assessment, patients with pulmonary nodules may need to draw blood for routine laboratory tests several times during diagnosis and treatment. There may be some blood samples to be discarded after the completion of routine tests. This clinical trial will only use these remaining blood samples as research samples. The samples collected in this part of the study were serum samples from patients with pulmonary nodules, and 50 subjects were planned to be enrolled.
Admission criteria: ① Pulmonary nodules were detected by imaging and surgically resected.
② Age 15-75 years old.
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Surgery or puncture is to be performed for pathological diagnosis.
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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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Benign nodule
Time Frame: A week
Pathological findings determined that the nodules were benign in the patient
Tumor
Time Frame: A week
Pathological findings identified the nodules as malignant tumors in the patient
Secondary Outcomes
No secondary outcomes reported