NCT05979623

Brief Summary

The goal of this observation study is to learn about clinicopathological characteristics and prognostic factors of stage IB NSCLC. The main question it aims to answer is wheather there is relationship between newly proposed clinicopathological features and the prognosis of stage IB NSCLC .The postoperative pathological and follow-up information of participants will be used for subsequent analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
971

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

4.9 years

First QC Date

July 29, 2023

Last Update Submit

July 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • RFS

    recurrence-free survival

    5 years

Secondary Outcomes (1)

  • OS

    5 years

Study Arms (1)

ZS-IB-NSCLC

A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from January 2016 to December 2020 at Zhongshan Hospital of Fudan University

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NSCLC patients with pathological stage IB resected by surgery (R0)

You may qualify if:

  • It was confirmed by histopathology as primary non-small cell lung cancer, and the pathological type was LUSC or LUAD;
  • According to the 8th edition of TNM clinical staging standards, it is determined as IB stage
  • No treatment was performed for the primary lesion of lung cancer before surgery;
  • No history of other malignant tumors before surgery;
  • Detailed clinical and pathological information, complete survival data, and no missing follow-up data.

You may not qualify if:

  • The postoperative histopathological types include non-scale and non adenocarcinoma, such as lung adenosquamous cell carcinoma, large cell lung cancer, or lung sarcomatoid carcinoma;
  • Multiple lesion staging surgery;
  • History of merging with other malignant tumors
  • Having preoperative treatment;
  • Missing follow-up information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Di Ge, Ph.D;M.D

    Zhongshan Hospital, Fudan University, Shanghai, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 7, 2023

Study Start

January 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2022

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations