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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007987

Enrollment

2994

Registered

2022-12-09

Start date

2022-12-30

Completion date

Unknown

Last updated

2023-01-10

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

Conditions

None listed

Interventions

Medical Device : Pulmonary nodules category 3 to 4 Perform AptoDetectTM-Lung and CEA test once at diagnosis and once at follow-up (optional).

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
AUROC(area under the receiver operating curve)	—

Secondary

Measure	Time frame
Sensitivity;specificity;positive predictive value; negative predictive value;false positive rate	—

Countries

Korea, Republic of

Contacts

Public ContactSeung Hyeun Lee

Kyung Hee University Hospital

humanmd04@hanmail.net+82-2-958-8511

Outcome results