Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

March 26, 2020 updated by: Chen KeZhong, Peking University People's Hospital

Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients

Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Study Overview

Status

Completed

Conditions

Detailed Description

For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

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

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100044
    - Peking University People's Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Histologically confirmed lung cancer patients who received completely tumor resection

Description

Inclusion Criteria:

Suspected lung cancer before surgery
No malignant tumor history within the past 5 years
The pulmonary nodule is not pure ground glass opacity
Patients must have given written informed consent

Exclusion Criteria:

Multiple primary lung cancer
R1,R2 resection
Histology confirmed not non-small cell lung cancer
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

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Half-life of circulating tumor DNA after surgery Time Frame: 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The variation of circulating tumor DNA level before and after surgery Time Frame: 3 months	3 months
Correlation of circulating tumor DNA level after surgery with tumor recurrence Time Frame: 3 years	3 years
Correlation of circulating tumor DNA level after surgery with clinical features Time Frame: 3 months	3 months

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

Collaborators

National Natural Science Foundation of China

Investigators

Study Chair: Jun Wang, M.D., Peking University 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

November 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 13, 2016

First Submitted That Met QC Criteria