Circulating Tumor DNA in Surgical Lung Cancer Patients

May 22, 2017 updated by: Shenzhen Gene Health Bio Tech Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chaoyu Liu, PhD
  • Phone Number: +8675588858978-808
  • Email: lcy@genehe.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shaolin Lin
        • Principal Investigator:
          • Youhui Qian
        • Principal Investigator:
          • Da Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgical lung cancer patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before surgery and 7days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Gene Health Bio Tech Co., Ltd.

Collaborators

Shenzhen People's Hospital
Shenzhen Second People's Hospital
Peking University Shenzhen Hospital

Investigators

  • Study Chair: Geng Tian, MD, Shenzhen Second People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 18, 2020

Study Registration Dates

First Submitted

March 12, 2017

First Submitted That Met QC Criteria

March 12, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GeneHealth-LC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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