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Differential diagnosis of benign and malignant pulmonary nodules based on transcriptome analysis of nasal epithelial cells and gDNA methylated NGS

Differential diagnosis of benign and malignant pulmonary nodules based on transcriptome analysis of nasal epithelial cells and gDNA methylated NGS

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040850
Enrollment
Unknown
Registered
2020-12-11
Start date
2020-08-01
Completion date
Unknown
Last updated
2021-04-12

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 diagnosis
Index test:GDNA&#32
detection&#32
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samples,

Sponsors

he First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years, regardless of gender. 2) A positive lung nodule is diagnosed by conventional chest CT or low-dose spiral CT (LDCT) and surgical resection is planned. In addition to the patients, three types of nodules (solid nodules, pure ground glass nodules, mixed ground glass nodules) can be included group, the size is 5~30mm. 3) Routine chest CT or LDCT scan was completed within 3 months before enrollment. 4) Willing to allow nasal mucosal epithelial cells, peripheral venous blood and surgically obtained pathological tissues according to the research protoco collection of biological samples such as FFPE. 5) The patient, guardian or close relatives can fully understand the informed consent form, agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant or breastfeeding women. 2) Have received any blood transfusion within 30 days before surgery. 3) The patient had any malignant tumor (except non-melanoma skin cancer) that was clearly diagnosed by pathology within 5 years before enrollment (does not include cured cervical cancer or breast adenocarcinoma). 4) The patient, guardian or close relatives cannot understand or sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactCheng Chao

The First Affiliated Hospital of Sun Yat-Sen University

drchengchao@163.com+86 13710763975

Outcome results

None listed

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