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CompletedNCT03413956Updated May 21, 2018

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

An observational study in Non Small Cell Lung Cancer, sponsored by Jiangsu Cancer Institute & Hospital. Completed at 10 sites in China. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Jiangsu Cancer Institute & Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,885
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Chinese
  • T1 non-small cell lung cancer
  • Lymph metastases
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The eligible subjects are the Chinese T1 patients with non-small cell lung cancer complicated with lymph metastases

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,885 participants (actual)
Patient registry
No

Groups and cohorts

  • NSCLC patients with lymph metastases

    Pathologically diagnosed patients with T1 non-small cell lung cancer complicated with lymph metastases after surgeries

    Procedure: Surgeries

Interventions

  • ProcedureSurgeries

    Surgeries

05

What researchers measure

Primary outcomes

  1. Percentage of the patients with lymph metastases

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

    Time frame: 2015 - 2017

Secondary outcomes

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

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

    Time frame: 2015 - 2017

Other outcomes

  1. Percentage of N2 patients with lymph nodes

    Percentages of N2 patients with lymph nodes in N2 population

    Time frame: 2015 - 2017

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

    Percentage of patients with lymph metastases categorised by tumor baseline characteristics

    Time frame: 2015 - 2017

  3. Number of lymph nodes in N2 patients

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

    Time frame: 2015 - 2017

  4. Percentage of patients with N2 skip metastases

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

    Time frame: 2015 - 2017

06

Study locations

10 sites
  • China-Japan Friendship Hospital
    Beijing, Beijing 100029, China
  • China People's Liberation Army Hospital
    Beijing, Beijing 100853, China
  • Henan cancer hospital
    Zhengzhou, Henan 450003, China
  • Henan Cancer Hospital
    Zhengzhou, Henan, China
  • Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University
    Wuhan, Hubei 430030, China
  • Jiangsu Cancer Institute and Hospital
    Nanjing, Jiangsu 210009, China
  • Xi'an Tangdu Hospital
    Xi'an, Shaanxi 710000, China
  • Shanghai Chest Hospital
    Shanghai, Shanghai 200030, China
  • West China Hospital
    Chengdu, Sichuan 610041, China
  • First Hospital Affiliated to Medical College, Zhejiang University
    Hangzhou, Zhejiang 310006, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03413956
Lead sponsor
Jiangsu Cancer Institute & Hospital
Responsible party
Feng Jiang (Associate professor, Jiangsu Cancer Institute & Hospital) — Principal investigator
First posted
Jan 29, 2018
Start date
Dec 1, 2017
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Last update
May 21, 2018

Study contacts

Lin Xu
principal investigator · Jiangsu Cancer Institute and Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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