Skip to content

Constructing a deep learning model for the differentiation of benign and malignant single solid small nodules based on multi-omics features: a prospective, multi-center clinical study

Constructing a deep learning model for the differentiation of benign and malignant single solid small nodules based on multi-omics features: a prospective, multi-center clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100041971
Enrollment
Unknown
Registered
2021-01-10
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

pulmonary nodules

Interventions

Gold Standard:Pathological results
Index test:The&#32
of&#32
deep&#32
learning&#32
model

Sponsors

Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-75 years, no gender limit; (2) Patients who plan to undergo complete resection of lung nodules or needle biopsy in our hospital; (3) Preoperative thin-slice CT examination revealed a single solid nodule with a diameter of <= 3cm in the lung, and no ground-glass nodules, pneumonia and other pulmonary manifestations exist; (4) No history of malignant tumors in the past 5 years and no neoadjuvant treatment before surgery; (5) No patients with distant metastasis or pleural and ascites found in preoperative evaluation; (6) Postoperative pathological diagnosis is clear; (7) Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: (1) Imaging examination cannot be performed due to pregnancy, breastfeeding, etc.; (2) No thin-slice CT examination records in the clinical center receiving treatment at the time of enrollment evaluation; (3) A history of lung infection one month before enrollment; (4) Have received blood transfusion treatment one month before enrollment, or have a history of alcohol or drug abuse; (5) Patients who cannot obtain enough blood samples (>=12ml); (6) Any conditions that are not suitable for blood sampling, such as anemia, fever, low autoimmunity, insufficiency of blood coagulation, etc.; (7) Patients with autoimmune diseases, blood system diseases, and infectious diseases.

Design outcomes

Secondary

MeasureTime frame
Sensitivity;specificity; positive predictive value ;negative predictive value ;

Primary

MeasureTime frame
area under the curve of the receiver operating characteristic ;accuracy;

Countries

China

Contacts

Public ContactChang Chen

Shanghai Pulmonary Hospital Affiliated to Tongji University

zhaosurgery@163.com+86 19916941894

Outcome results

None listed

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