A Study to Explore Prognoses of NSCLC Patients Complicate... | NCT03427541

Studies
A Study to Explore Prognoses of NSCLC Patients Complicated With Oligometastases

NCT03427541

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Feb 9, 2018Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Surgeries

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

Feb 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

Dec 31, 2017Actual

Primary Completion Date

Apr 30, 2018Estimated

Completion Date

Apr 30, 2018Estimated

First Submitted Date

Feb 2, 2018

First Submission Date that Met QC Criteria

Feb 7, 2018

First Posted Date

Feb 9, 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

Feb 7, 2018

Last Update Posted Date

Feb 9, 2018Actual

Name	Class
LinkDoc Technology (Beijing) Co. Ltd.	INDUSTRY

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

An observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases

Detailed Description

A multi-centre real-world non-interventional observational study to explore prognoses and clinical treatments of the patients with non-small lung cancer complicated with oligometastases

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with surgeries		NSCLC patients with surgeries	Procedure: Surgeries

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgeries	Procedure	Surgeries	Patients with surgeries

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival	2014 - 2017

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival	Disease-free survival	2014 - 2017

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically diagnosed patients with non-small cell lung cancer;
Tumor metastases in one organ (no more than 3 metastases);

Exclusion Criteria:

Patients with intrapulmonary metastases or multiple primary tumors;
Patients with pleural dissemination or invasion of extrapulmonary organs;
Patients with supraclavicular lymph node metastasis;
Patients with systematic diseases that would influence patient survivals;
Patients with no records for visits;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pathologically diagnosed patients with non-small cell lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haiying Yang, PhD	Contact	0086-010-62680809		celineyang@linkdoc.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China-Japan Friendship Hospital	Recruiting	Beijing	Beijing Municipality	100029	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

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided