NCT03790735

The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules

Targeted Chromosomal Aberrations Detection by FISH Analysis of Circulating Abnormal Cells to Differentiate of Benign and Malignant Pulmonary Nodules

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Nodule, Solitary

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FISH	Targeted chromosomal aberrations detection

Timeline

• Start date: 2018-05-03
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2019-01-02
• Last updated: 2019-01-02

Locations

1 site across 1 country: China