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NCT03081741 Clinical Trial

Circulating Tumor DNA in Surgical Lung Cancer Patients

Lung Neoplasms Clinical Trial

Official title:
A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03081741
Other study ID # GeneHealth-LC-01
Secondary ID
Status Recruiting
Phase N/A
First received March 12, 2017
Last updated May 22, 2017
Start date May 3, 2017
Est. completion date March 18, 2020

Study information
Verified date May 2017
Source Shenzhen Gene Health Bio Tech Co., Ltd.
Contact Chaoyu Liu, PhD
Phone +8675588858978-808
Email lcy@genehe.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.

Description:

Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.

The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date March 18, 2020
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent

Exclusion Criteria:

Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Shenzhen Second People's Hospital Shenzhen Guangdong

Sponsors (4)
Lead Sponsor Collaborator
Shenzhen Gene Health Bio Tech Co., Ltd. Peking University Shenzhen Hospital, Shenzhen People's Hospital, Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of surgery on ctDNA of lung cancer patients Changes of blood ctDNA of lung cancer patients before and after surgery. before surgery and 7days after surgery
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