Prospective Study of Serum Marker LncRNA RP5-977B1 in Pulmonary Nodules

Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodule; Tumor of Lung

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Zijian Wu, Learned; Phone Number: 3707 020-66673666; Email: 463596459@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510095
      • Recruiting
      • Cancer Hospital & Affiliated Guangzhou Medical University
      • Contact: Ling Min, Learned; Phone Number: 3639 020-66673666; Email: minling1977@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Serum samples from patients with radiographic findings and surgical removal of pulmonary nodules were selected.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Benign nodule; Pulmonary nodules were detected by imaging and surgically resected.Age 15-75 years old.Surgery or puncture is to be performed for pathological diagnosis. ④ 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.
Tumor; Pulmonary nodules were detected by imaging and surgically resected.Age 15-75 years old.Surgery or puncture is to be performed for pathological diagnosis. ④ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benign nodule	Pathological findings determined that the nodules were benign in the patient	A week
Tumor	Pathological findings identified the nodules as malignant tumors in the patient	A week

Collaborators and Investigators

• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Investigators: Study Chair: Zijian Wu, Learned, Cancer Hospital & Affiliated Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; RP5-977B1; LncRNA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: IIT-2023-013(JYK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the requirements of the institution and the need to protect the privacy of patients, it is not convenient to disclose IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No