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Circulating Tumor DNA in Surgical Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT03081741
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborators:
Shenzhen People's Hospital
Shenzhen Second People's Hospital
Peking University Shenzhen Hospital
Information provided by (Responsible Party):
Shenzhen Gene Health Bio Tech Co., Ltd.

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

Condition or disease
Lung Neoplasms

Detailed 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.


Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Lung Cancer Patients
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : March 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Effect of surgery on ctDNA of lung cancer patients [ Time Frame: before surgery and 7days after surgery ]
    Changes of blood ctDNA of lung cancer patients before and after surgery.


Biospecimen Retention:   Samples With DNA
Blood samples and FFPE tissue sections were collected from each patient.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical lung cancer patients.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081741


Contacts
Contact: Chaoyu Liu, PhD +8675588858978-808 lcy@genehe.com
Contact: Xiaohua Li, PhD +8675588858978-808 lixiaohua@genehe.com

Locations
China, Guangdong
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Geng Tian, MD       tiangeng666@aliyun.com   
Contact: Chaoyu Liu, PhD       lcy@genehe.com   
Principal Investigator: Shaolin Lin         
Principal Investigator: Youhui Qian         
Principal Investigator: Da Wu         
Sponsors and Collaborators
Shenzhen Gene Health Bio Tech Co., Ltd.
Shenzhen People's Hospital
Shenzhen Second People's Hospital
Peking University Shenzhen Hospital
Investigators
Study Chair: Geng Tian, MD Shenzhen Second People's Hospital

Responsible Party: Shenzhen Gene Health Bio Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03081741     History of Changes
Other Study ID Numbers: GeneHealth-LC-01
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases