The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules

• Conditions: Pulmonary Nodule, Solitary
• Interventions: Diagnostic Test: FISH

• Registration Number: NCT03790735
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

* The purpose of the study is the identification of the efficacy of MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules.

* In this study, the investigators are going to validate the efficacy of the MDA test for diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the post-surgery pathology.

Detailed Description

* Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.

* This study is being conducted to evaluate the efficacy of the MDA TEST to detect Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample type of MDA test is Peripheral Blood. This study will compare the results of the pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect lung cancer or the lack of lung cancer .

* The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

Study Timeline

• Study Start: 2018-05-03
• Status Verified: 2018-12
• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2018-12-31
• Last Update Submitted: 2018-12-31
• Study First Posted: 2019-01-02
• Last Update Posted: 2019-01-02
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years old or above
• single pulmonary nodule found by CT scan.
• the diameter of the pulmonary nodule is between 5mm to 30mm.
• plan to accept pneumonectomy due to the pulmonary nodule.
• agree to sign informed consent

Exclusion Criteria

• fail to understand or agree to sign informed consent.
• pregnant or lactating women.
• the diameter of the pulmonary nodule is more than 30mm.
• there are 2 or more pulmonary nodules in one single patient.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic test	FISH	Targeted chromosomal aberrations detection by FISH (MDA TEST).

Primary Outcome Measures

Name	Time	Method
Early detection of lung cancer	6 months	The efficacy of the MDA TEST assay comparing with pathologic diagnosis(the gold standard), and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, China