A Real-world Study to Explore Recurrence/Metastases of the NSCLC Patients and the Impact Factors of Patient Survivals

July 31, 2019 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

A Real-world Study to Explore Recurrence/Metastases of the Early-stage (I-IIIA) NSCLC Patients and the Impact Factors of Patient Survivals

The real-world study was designed to explore recurrence/metastases of the patients with non-small cell lung cancer as measured by patient survivals and the impact factors of patient survivals.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The trial was designed as a real-world observational study to recruit those patients with pathologically diagnosed early-phase non-small cell lung cancer (NSCLC) who were enrolled in the clinical form 2009 to 2017 and explore recurrence/metastases of the NSCLC patients as measured by patient survivals and the impact factors of patient survivals. The study data on patient demographic characteristics, tumor biological characteristics, and clinicla treatments were collected via a retrospectively review method for evaluation of patient survivals and the relevance of clinical characteristics of the patients and patient survivals.

Study Type

Observational

Enrollment (Anticipated)

700

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

Study Contact Backup

Study Locations

  • China
    • Guangzhou
      • Guangzhou, Guangzhou, China
        • Recruiting
        • Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
          • Wenhua Liang, PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologically diagnosed early-stage (I-IIIA) NSCLC patients who were operated with radical operations of the lung cancer

Description

Inclusion Criteria:

The patients who meet all the following inclusion criteria will be included in the study:

  • The patients who were operated with radical operations of the lung cancer;
  • The patients with clinical I-IIIA staging tumors;
  • The pathologically diagnosed NSCLC patients;

Exclusion Criteria:

- Not be specified;

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
Disease-free survival rates within the configured observation periods
Time Frame: 2009-2017
Disease-free survival rates within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;
2009-2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival rates at the configured locations and observation periods
Time Frame: 2009-2017
Disease-free survival rates at the metastasized lymph nodes, bone, and brain within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;
2009-2017

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact factors of disease-free survival rates
Time Frame: 2009-2017
Impact factors of disease-free survival rates
2009-2017
Overall rates
Time Frame: 2009-2017
Overall rates within 3 month-, 6 month-, 1 year-, 2 year-, and 3 year- observation periods
2009-2017
Rates of perioperative complications
Time Frame: 2009-2017
Rates of perioperative complications
2009-2017

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Wenhua Liang, Ph.D, The First Affiliated Hospital of Guangzhou Medical University

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)

March 24, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZH-001

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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