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NCT Number: NCT03413956

An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer

The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

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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

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

The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who received surgeries from 2015 to 2017;
  • Pathologically diagnosed patients with T1 non-small cell lung cancer;

Exclusion criteria

  • Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)

Treatment and study plan

Surgeries

Procedure

Surgeries

Primary outcomes

  1. Percentage of the patients with lymph metastases

    Time frame: 2015 - 2017

    Percentages of the patients with lymph metastases categorised by patient demographic and tumor biological characteristics

Secondary outcomes

  1. Percentages of N0/N1/N2/N3 patients

    Time frame: 2015 - 2017

    Percentages of N0/N1/N2/N3 patients in the target population

Other outcomes

  1. Percentage of N2 patients with lymph nodes

    Time frame: 2015 - 2017

    Percentages of N2 patients with lymph nodes in N2 population

  2. Percentage of patients with lymph metastases categorised by tumor baseline characteristics

    Time frame: 2015 - 2017

    Percentage of patients with lymph metastases categorised by tumor baseline characteristics

  3. Number of lymph nodes in N2 patients

    Time frame: 2015 - 2017

    Number of lymph nodes in N2 patients categorised by tumor baseline characteristics

  4. Percentage of patients with N2 skip metastases

    Time frame: 2015 - 2017

    Percentage of patients with N2 skip metastases categorised by tumor baseline characteristics

Sponsors and collaborators

Lead sponsor

Jiangsu Cancer Institute & Hospital

Other

Registry information

Official study title

A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of the Chinese Patients With T1 Non-small Cell Lung Cancer Complicated With Lymph Metastases

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 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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