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NCT Number: NCT03429192

A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer

A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China People's Liberation Army Hospital, Beijing, Beijing Municipality, China

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About this study

A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with surgeries from 2014 to 2017;
  • Pathologically diagnosed patients with non-small cell lung cancer;
  • Age > 18 years old;
  • Patients with chest surgeries before hospitalization;
  • Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);

Exclusion criteria

  • Patients with radiotherapies, chemotherapies and biological therapies for tumors

Treatment and study plan

Surgery

Procedure

Surgeries plus dissection of lymph nodes

Primary outcomes

  1. Difference in overall survival (OS)

    Time frame: 2014 - 2017

    OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases

Secondary outcomes

  1. Percentage of N2 patients with lymph skip metastases

    Time frame: 2014 - 2017

    Percentage of N2 patients with lymph skip metastases

Other outcomes

  1. Difference in overall survival (OS) (in the subgroups of patients)

    Time frame: 2014 - 2017

    OS difference in subgroups of patients with lymph skip metastases and non-skip metastases categorised by baseline characteristics

  2. Hazard factors of overall survival

    Time frame: 2014 - 2017

    Hazard factors of overall survival

Sponsors and collaborators

Lead sponsor

Tianjin Chest Hospital

Other

Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

Registry information

Official study title

A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of Lymph Skip Metastases and Prognoses of N2 Patients With Non-small Cell Lung Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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