A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer

May 18, 2018 updated by: lixiaofei, Tang-Du Hospital

A Multi-centre Real-world Non-interventional Observational Study to Compare Prognoses of the Chinese Patients With N2 Non-small Cell Lung Cancer Who Received Adjuvant Chemotherapies and Perioperative Chemotherapies After Surgeries

The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2929

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, 100029
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China, 100853
        • China PLA General Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Huazhong Technology Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xi'an Tangdu Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Shanghai Chest Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Huaxi Hospital Affiliated to Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300051
        • Tianjin Chest Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • First Hospital Affiliated to Zhejiang University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologically diagnosed Chinese patients with N2 non-small cell lung cancer who received radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies

Description

Inclusion Criteria:

  • Patients with radical resection of lung cancer enrolled from 2014 to 2019;
  • Pathologically diagnosed patients with non-small cell lung cancer;
  • Patients with age > 18 years old;
  • Patients who did not receive chest surgeries before hospitalization;
  • Patients with N2 lymph nodes (+) after surgeries;
  • Patients who received lymphadenectomy for one group or more groups of lymph nodes;

Exclusion Criteria:

  • Patients with second primary tumors or multiple primary tumors;

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-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Surgeries+adjuvant chemotherapies
Patients who received radical resection of lung cancer + adjuvant chemotherapies
Procedure: Surgeries
Surgeries plus adjuvant chemotherapies or perioperative chemotherapies
Other Names:
  • Adjuvant chemotherapies or perioperative chemotherapies
Perioperative chemotherapies
Patients who received perioperative chemotherapies
Procedure: Surgeries
Surgeries plus adjuvant chemotherapies or perioperative chemotherapies
Other Names:
  • Adjuvant chemotherapies or perioperative chemotherapies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2014 - 2017
Overall survival
2014 - 2017

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 2014 - 2017
Disease-free survival
2014 - 2017

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survivals in the subgroups
Time Frame: 2014 - 2017
Overall survivals in the subgroups categorized by T staging
2014 - 2017
Disease-free survivals in the subgroups
Time Frame: 2014 - 2017
Disease-free survivals in the subgroups categorized by T staging
2014 - 2017
Impact factors of overall survival as measured by age
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by age
2014 - 2017
Impact factors of overall survival as measured by gender
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by gender
2014 - 2017
Impact factors of overall survival as measured by BMI
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by BMI
2014 - 2017
Impact factors of overall survival as measured by tumor size
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by tumor size
2014 - 2017
Impact factors of overall survival as measured by tumor location
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by tumor location
2014 - 2017
Impact factors of overall survival as measured by T staging
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by T staging
2014 - 2017
Impact factors of overall survival as measured by clinical treatments
Time Frame: 2014 - 2017
Impact factors of overall survival as measured by surgeries plus adjuvant chemotherapies and surgeries plus perioperative chemotherapies
2014 - 2017
Time to local recurrence
Time Frame: 2014 - 2017
Time to local recurrence
2014 - 2017
Time to distant recurrence
Time Frame: 2014 - 2017
Time to distant recurrence
2014 - 2017
Death rate within 30/90 days after surgeries
Time Frame: 2014 - 2017
Death rate within 30/90 days after surgeries
2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics
Time Frame: 2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by patient demographic characteristics
2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics
Time Frame: 2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by tumor biological characteristics
2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries
Time Frame: 2014 - 2017
Impact factors of death rate within 30/90 days after surgeries as measured by various modes of surgeries
2014 - 2017
Incidence of perioperative complications
Time Frame: 2014 - 2017
Incidence of perioperative complications
2014 - 2017

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tang-Du Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LinkDoc Technology (Beijing) Co. Ltd.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W-TONG04

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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