The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules

Pulmonary Nodule, Solitary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03790735
• Other study ID #: TianjinCIH2018
• Status: Recruiting
• Start date: May 3, 2018
• Est. completion date: June 2019

Study information

• Verified date: December 2018
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Dongyan Cheng
• Phone: (022)23340123-6012
• Email: chengdongyan916[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Diagnostic Test:
• FISH
Targeted chromosomal aberrations detection

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Zhuhai livzon cynvenio diagnostics LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early detection of lung cancer	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).	6 months