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Diagnostic Value of Serum Anti-CENPF Autoantibodies in Ground-Glass Nodule-Associated Lung Adenocarcinoma: A Multicenter Prospective Trial

Diagnostic Value of Serum Anti-CENPF Autoantibodies in Ground-Glass Nodule-Associated Lung Adenocarcinoma: A Multicenter Prospective Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129096
Enrollment
Unknown
Registered
2026-07-30
Start date
2026-07-30
Completion date
Unknown
Last updated
2026-08-03

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:Postoperative pathology was the gold standard according to the 2021 edition of WHO"Pathological diagnostic criteria for lung tumors", which was finally approved by two senior pathologist
Index test:Serum autoantibodies against CENPF

Sponsors

Tangdu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients must meet all the following criteria to be enrolled in this study: 1. The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up. 2. Age >=18 years and =1.5×10^9/L and white blood cell count >=3.5×10^9/L within the past 14 days without granulocyte colony-stimulating factor use; (2) Platelet count >=90×10^9/L within the past 14 days without blood transfusion; (3) Hemoglobin >90 g/L within the past 14 days without blood transfusion or erythropoietin use.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will not be enrolled in this study: 1. Prior history of lung cancer or other malignancies. 2. Received neoadjuvant therapy (chemotherapy, radiotherapy, targeted therapy) before surgery. 3. Preoperative blood sample collection failed or the sample quality was inadequate. 4. Preoperative imaging shows pure solid component. 5. Severe cardiac insufficiency, cardiac function class III or above; severe renal insufficiency, in the failure stage or uremic stage; or other conditions that make the patient unable to tolerate surgery.

Design outcomes

Primary

MeasureTime frame
The accuracy (AUC value) of serum anti-CENPF autoantibody levels in differentiating whether patients with imaging manifestations of GGN are invasive lung adenocarcinoma;

Secondary

MeasureTime frame
The sensitivity, specificity, positive predictive value and negative predictive value of serum anti-CENPF autoantibody levels in diagnosing patients with imaging manifestations of GGN as having invasive lung adenocarcinoma.;Evaluating the diagnostic efficacy of serum anti-CENPF autoantibody levels in predicting pathological diagnosis of invasive adenocarcinoma (IAC) (compared with CEA, CYFRA21-1 and imaging features);Draw the ROC curve to evaluate the diagnostic value of CENPF antibody levels for pathological type IAC (compared with indicators such as CTR);

Countries

China

Contacts

Public ContactLei Jie

Tangdu Hospital

wkqky_td@163.com+86 195 6768 6033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026