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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03790735
Other study ID # TianjinCIH2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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