Skip to content

Bai-DX & MDA TEST: a Multicenter Clinical Study for Auxiliary Diagnosis in Differentiating Benign From Malignant Pulmonary Nodule in China

Bai-DX & MDA TEST: a Multicenter Clinical Study for Auxiliary Diagnosis in Differentiating Benign From Malignant Pulmonary Nodule in China

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026233
Enrollment
Unknown
Registered
2019-09-28
Start date
2019-09-30
Completion date
Unknown
Last updated
2019-09-30

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:The histopathological classification in this study was based on 2015 WHO Histological Classification of Lung Cancer, while the staging of cancer was based on the Eighth Edition of the AJ
Index test:Bai-DX & MDA TEST

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects who were identified with <= 30mm single or multiple pulmonary nodule by CT/LDCT in the past 6 months. 2. Subjects who were at least 18 years old. 3. Subjects who planned to receive pulmonary nodule non-surgical biopsy or surgical removal and did pathological examinations. 4. Subjects who volunteered for this clinical study and had given written informed consent, prior to treatment.

Exclusion criteria

Exclusion criteria: 1. Subjects who were pregnant, trying to get pregnant or nursing. 2. Subjects who had severe cardiac, pulmonary, hepatic dysfunction or mental disorders. 3. Subjects who received clinical interventions in lung cancer, such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy etc. 4. Subjects whose samples could not meet the pathological examination requirements of investigational center. 5. Subjects who were known to have a history of malignant tumors in the past 5 years.

Design outcomes

Primary

MeasureTime frame
CAC;SEN, SPE, ACC, AUC of ROC, +LR, -LR;

Countries

China

Contacts

Public ContactChunxue Bai

Zhongshan Hospital, Fudan University

bai.chunxue@zs-hospital.sh.cn+86 18621170011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026