Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531850
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Prospective Study of Serum Marker LncRNA RP5-977B1 in Pulmonary Nodules
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ① Patient samples have hemolysis have been contaminated have been placed for too long have insufficient sample allowance and have mixed records
History of malignant tumor
Serious underlying diseases and complications may affect systemic treatment ④ Can not guarantee to receive blood tests on time
Received anti-tumor Chinese medicine immunization chemotherapy and other treatments within 2 weeks
Exclusion criteria ① Subjects who do not meet the inclusion criteria or who meet the exclusion criteria and are mistakenly enrolled
Samples collected for two or more times from the same patient should be retained only the samples collected for the first time and all subsequent samples collected should be excluded
Samples with incomplete case information ④ Sample quality control unqualified samples due to sample collection storage transportation and other reasons
Samples that cannot be tested due to instruments and other reasons
Admission criteria ① Pulmonary nodules were detected by imaging and surgically resected
② 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 ① Patient samples have hemolysis have been contaminated have been placed for too long have insufficient sample allowance and have mixed records
History of malignant tumor
Serious underlying diseases and complications may affect systemic treatment ④ Can not guarantee to receive blood tests on time
Received anti-tumor Chinese medicine immunization chemotherapy and other treatments within 2 weeks
Exclusion criteria ① Subjects who do not meet the inclusion criteria or who meet the exclusion criteria and are mistakenly enrolled
Samples collected for two or more times from the same patient should be retained only the samples collected for the first time and all subsequent samples collected should be excluded
Samples with incomplete case information ④ Sample quality control unqualified samples due to sample collection storage transportation and other reasons
Samples that cannot be tested due to instruments and other reasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None