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Construction of a differential diagnosis system for benign and malignant pulmonary nodules based on multi-omics

Construction of a differential diagnosis system for benign and malignant pulmonary nodules based on multi-omics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077871
Enrollment
Unknown
Registered
2023-11-22
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Gold Standard:Pathological Results of Pulmonary Nodules
Index test:To establish a multi-dimensional diagnosis and treatment system for pulmonary nodules by conducting tests at multiple levels such as tissue cytology, protein, LncRNA, methylation, etc. : 1)
2) LncRNA including MALAT1/HOTAIR/GAS5 and other levels
3) Tumor-associated autoantibodies (T-AABs) include p53, PGP9.5, SOX2, GAGE7, GBU4-5, MEGEA1, CAGE, etc.

Sponsors

The second affiliated Hospital of Army military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) When signing the informed consent form, the age is =18 years old and =75 years old; 2) Women with reproductive potential must have a negative pregnancy test (serum or urine) at the time of screening and have no pregnancy plans during the study; 3) Chest CT/HRCT and other imaging findings suggest the presence of single or multiple solid, mixed or ground-glass pulmonary nodules; 4) Willing, able and agreeing to follow the baseline and follow-up assessments required by the study; 5) Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Uncontrollable diabetes, such as HbA1c>7%; 2) Myocardial infarction occurred within 6 months in the past, and EKG (electrocardiogram) showed evidence of life-threatening arrhythmia or acute ischemia, with previous LVEF<45%, stage C or D (ACC/AHA) or class III or Evidence of Class IV (NYHA) congestive heart failure, or any other prior or current cardiac disease that renders the patient intolerant of general anesthesia for bronchoscopy; 3) Known contraindications or drug allergies to the required bronchoscopy or general anesthesia, which cannot be controlled by drugs; 4) According to the anatomical structure of the bronchi shown on chest CT, it is speculated that the bronchofiberscope cannot reach the lung nodules for biopsy; 5) Patients who have been clearly diagnosed with lung cancer in the past; 6) Patients with other systemic active malignant tumors; 7) Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Methylation levels of SHOX2 and RASFF1A gene promoters;Sensitivity;Specificity;

Secondary

MeasureTime frame
LncRNA(MALAT1/HOTAIR/GAS5);

Countries

China

Contacts

Public ContactXu Zhi

The second affiliated Hospital of Army military Medical University

xu_zhi999@163.com+86 139 8341 7718

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026