NCT03413956

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,885

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

January 15, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

ChineseT1 non-small cell lung cancerLymph metastases

Outcome Measures

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

    2015 - 2017

Secondary Outcomes (1)

  • Percentages of N0/N1/N2/N3 patients

    2015 - 2017

Other Outcomes (4)

  • Percentage of N2 patients with lymph nodes

    2015 - 2017

  • Percentage of patients with lymph metastases categorised by tumor baseline characteristics

    2015 - 2017

  • Number of lymph nodes in N2 patients

    2015 - 2017

  • +1 more other outcomes

Study Arms (1)

NSCLC patients with lymph metastases

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

Procedure: Surgeries

Interventions

SurgeriesPROCEDURE

Surgeries

NSCLC patients with lymph metastases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

China People's Liberation Army Hospital

Beijing, Beijing Municipality, 100853, China

Location

Henan cancer hospital

Zhengzhou, Henan, 450003, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University

Wuhan, Hubei, 430030, China

Location

Jiangsu Cancer Institute and Hospital

Nanjing, Jiangsu, 210009, China

Location

Xi'an Tangdu Hospital

Xi'an, Shaanxi, 710000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

First Hospital Affiliated to Medical College, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lin Xu

    Jiangsu Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 29, 2018

Study Start

December 1, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations