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

NCT ID: NCT06531850

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-01-01

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.

Conditions

Tumor of Lung; Pulmonary Nodule

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zijian Wu, Learned

Role: STUDY_CHAIR

Cancer Hospital & Affiliated Guangzhou Medical University

Locations

Cancer Hospital & Affiliated Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zijian Wu, Learned

Role: CONTACT

463596459@qq.com

020-66673666 ext. 3707

Facility Contacts

Ling Min, Learned

Role: primary

minling1977@163.com

020-66673666 ext. 3639

Other Identifiers

IIT-2023-013(JYK)

Identifier Type: -

Identifier Source: org_study_id