NCT04266691

Brief Summary

Analysis of driver gene variation in early stage non-small cell lung cancer

Trial Health

100
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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, 2009

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

6.9 years

First QC Date

February 6, 2020

Last Update Submit

February 9, 2020

Conditions

Keywords

Regional Lymph nodesMolecular metastasisDriver gene mutation

Outcome Measures

Primary Outcomes (3)

  • Driver gene mutation frequency of early stage NSCLC

    Observe the driver gene mutation frequency in regional lymph nodes of early stage non-small cell lung cancer

    2019

  • Correlation of Clinicopathological characteristics and driver gene mutation in regional lymph nodes of early stage NSCLC

    Analyze the correlation between driver gene mutation and clinicopathological features in regional lymph nodes of early stage NSCLC

    2019

  • Correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC

    Observe the correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC

    2019

Study Arms (2)

Driver gene mutation-positive

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation positive.

Other: nonIntervention

Driver gene mutation-negative

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation negative.

Other: nonIntervention

Interventions

nonIntervention

Driver gene mutation-negativeDriver gene mutation-positive

Eligibility Criteria

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

Histologically or cytologically proven diagnosis of early stage NSCLC

You may qualify if:

  • Female or male, 18 years of age or older
  • Histologically or cytologically proven diagnosis of early stage NSCLC
  • The lesion was completely resected by radical surgery
  • Able to get tumor tissue sample
  • Complete information of clinicopathological , survival, recurrence and metastasis can be obtained through follow-up

You may not qualify if:

  • Combine with other tumor type
  • The investigator judges the situation that may affect the clinical search process and results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tian Y, Lai Q, Zheng Y, Ying L, Wang C, Jin J, Huang M, Wu Y, Li H, Zhang J, Su D. Oncogenic Alterations in Histologically Negative Lymph Nodes Are Associated with Prognosis of Patients with Stage I Lung Adenocarcinoma. Cancers (Basel). 2022 Feb 6;14(3):824. doi: 10.3390/cancers14030824.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of pathology

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 12, 2020

Study Start

January 1, 2009

Primary Completion

December 1, 2015

Study Completion

June 1, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share