NCT03301961

Brief Summary

Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

September 30, 2017

Last Update Submit

February 4, 2020

Conditions

CarcinomaNon-small-cell Lung CancerLung Neoplasm

Keywords

Circulating Tumor DNAEarly diagnosisSurveillanceMethylationSomatic mutation

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer

    12 months

Secondary Outcomes (3)

  • Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer

    12 months

  • The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection

    36 months

  • Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches

    36 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patient are found nodules in pulmonary and prepare for surgery

You may qualify if:

  • Sign informed consent and consent to participate in this study;
  • Found small nodules in pulmonary by CT and prepare for surgery;

You may not qualify if:

  • Malignant tumor history within the past 5 years;
  • Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
  • No matching tissue or blood samplesUnqualified blood samples
  • Lesion is pure ground glass opacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A series of lung cancer patients plasma before and after surgery

MeSH Terms

Conditions

CarcinomaCarcinoma, Non-Small-Cell LungLung NeoplasmsDisease

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kezhong Chen, MD

    Peking University People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Kezhong Chen, MD

CONTACT

（+86）13488752289mdkzchen@163.com

Heng Zhao, MD

CONTACT

（+86）13683139396zhaohengzhaoheng@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief，Thoracic Surgery Service

Study Record Dates

First Submitted

September 30, 2017

First Posted

October 4, 2017

Study Start

April 11, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2022

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

CN(1)