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

NCT06531850 | Unknown

• 1 other identifier: IIT-2023-013(JYK)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor of Lung; Pulmonary Nodule

Keywords

lung cancer; RP5-977B1; LncRNA

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Cancer Hospital & Affiliated Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zijian Wu, Learned

  Cancer Hospital & Affiliated Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Zijian Wu, Learned

CONTACT

020-66673666; 463596459@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)