Multicenter clinical evaluation study of clinical effectivity of AptoDetectTM-Lung for Auxiliary diagnostics of Non-Small Cell Lung Cancer

Not Applicable

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0007987
• Lead Sponsor: Kyung Hee University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 2994

Inclusion Criteria

1) A patient who has given written consent to participate in this study
2) Adult men and women over 19 years of age
3) Patients with solid nodules or part solid nodules corresponding to categories 3 to 4 according to the Lung-RADS® version 1.1 pulmonary nodule categorization guidelines
However, patients in category S according to the Lung-RADS® version 1.1 pulmonary nodule categorization guidelines can also be enrolled.

Exclusion Criteria

1) Patients with ground glass nodules (GGO) in the Lung-RADS® version 1.1 pulmonary nodule categorization guidelines
2) Any pulmonary infection requiring current treatment (both oral or intravenous)
However, if the researcher determines that treatment for lung infection has been completed, enrollment is possible.
3) Patients with histologically confirmed malignant tumors prior to participation in this study
However, registration is possible in the following cases, but registration is not possible if the patient is accompanied by a malignant tumor requiring current treatment.
? Cases confirmed as malignant tumors (including lung cancer) but in remission for more than 5 years after completion of treatment
? Effectively treated non-melanoma skin cancer, cervical carcinoma in situ, mammary ductal carcinoma in situ, localized prostate cancer treated for curative purposes, and thyroid cancer can be registered.
4) Pregnant women

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUROC(area under the receiver operating curve)

Secondary Outcome Measures

Name	Time	Method
Sensitivity;specificity;positive predictive value; negative predictive value;false positive rate