A Study to Explore Treatment Regimens and Clinical Outcom... | NCT03710629

Studies
A Study to Explore Treatment Regimens and Clinical Outcomes of the NSCLC Patients With Different Dirver Genes

NCT03710629

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Status

Unknown status

Last Update Posted

Oct 18, 2018Actual

Enrollment

750Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Patients with driver genes

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jul 10, 2018

First Submission Date that Met QC Criteria

Oct 15, 2018

First Posted Date

Oct 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2018

Last Update Posted Date

Oct 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianxing He, Professor, The First Affiliated Hospital of Guangzhou Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Guangzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The trial was designed as a single-center non-interventional prospective observational study to explore clinical treatments of the NSCLC patients with different driver genes, the impact factors of patient survivals, and the relevance of gene types, clinical treatments, and distribution of gene types. The follow-up visits, interactions between the investigators and patients, patient questionnaires/quality of life, and other patient information will be uploaded via mobile APP, and webchat every three months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSCLC patients with driver genes		NSCLC patients and driver genes	Other: Patients with driver genes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with driver genes	Other	Patients with driver genes	NSCLC patients with driver genes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in overall survival rates	Differences in overall survival rates of the NSCLC patients with various gene types	2018-2022

Secondary Outcomes

Measure	Description	Time Frame
Interaction impact between gene types and treatment modalities or regimens on disease-free survivals	Interaction impact between gene types and treatment modalities or regimens on disease-free survivals	2018-2022
Statuses of clinical treatment regimens

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

-None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianxing HE, MD	Contact	00862083062114		hejx@vip.163.com
Wenhua LIANG, Ph.D	Contact	00862083062114		liangwh1987@163.com

Overall Officials

Name	Affiliation	Role
Wenhua Liang, Ph.D	The First Affiliated Hospital of Guangzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wenhua of Liang	Recruiting	Guangzhou	Guangdong	510120	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided