Clinical trial NCT06531850: Prospective Study of Serum Marker LncRNA RP5-977B1 in Pulmonary Nodules
Official title: Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor of Lung
Pulmonary Nodule
Keywords: lung cancer; RP5-977B1; LncRNA
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Serum samples from patients with radiographic findings and surgical removal of pulmonary nodules were selected.

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.

Eligibility 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.

Primary outcomes:
measure: Benign nodule
timeFrame: A week
measure: Tumor
timeFrame: A week
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Hospital & Affiliated Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Cancer Hospital & Affiliated Guangzhou Medical University
name: Zijian Wu, Learned
role: STUDY_CHAIR
References: