NCT03710629

Brief Summary

A single-center, non-interventional prospective observational study in the NSCLC patients with different driver genes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

4.4 years

First QC Date

July 10, 2018

Last Update Submit

October 15, 2018

Conditions

Keywords

Non-small cell lung cancer, gene mutations

Outcome Measures

Primary Outcomes (1)

  • Differences in overall survival rates

    Differences in overall survival rates of the NSCLC patients with various gene types

    2018-2022

Secondary Outcomes (7)

  • Interaction impact between gene types and treatment modalities or regimens on disease-free survivals

    2018-2022

  • Statuses of clinical treatment regimens

    2018-2022

  • Relevance of gene types

    2018-2022

  • Relevance of overall survival rates and gene types

    2018-2022

  • Impacts of disease-free survivals on gene types

    2018-2022

  • +2 more secondary outcomes

Study Arms (1)

NSCLC patients with driver genes

NSCLC patients and driver genes

Other: Patients with driver genes

Interventions

Patients with driver genes

NSCLC patients with driver genes

Eligibility Criteria

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

The pathologically diagnosed patients with non-small cell lung cancer who were performed with NGS technology

You may qualify if:

  • The patients with lung cancer who were performed with next-generation sequencing (NGS) technology from 2015 to 2017;
  • The patients who were at least 18 years;
  • The pathologically diagnosed patients with non-small cell lung cancer (NSCLC)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenhua of Liang

Guangzhou, Guangdong, 510120, China

RECRUITING

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

  • Wenhua Liang, Ph.D

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing HE, MD

CONTACT

Wenhua LIANG, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2018

First Posted

October 18, 2018

Study Start

July 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations