A Nation-wide Multicenter Clinical Epidemiologic Study of... | NCT03047889

Status Module

Record Verification Date

Feb 2017

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

Apr 2016

Primary Completion Date

Apr 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 29, 2016

First Submission Date that Met QC Criteria

Feb 7, 2017

First Posted Date

Feb 9, 2017Estimated

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, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Binghe Xu, Professor, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results

Detailed Description

In this study, the investigators conducted a hospital-based retrospective clinical study, recruiting female advanced breast cancer patients from 14 tertiary hospitals at 7 classic geographic regions, to study the clinical epidemiologic characteristics of advanced breast cancer and the current standard of clinical diagnosis and treatment in order to provide references for standardized treatment therapy, and to improve the quality of life and prolong survival time.

To study the epidemiological trends and characteristics for advanced BC patients, to analyze these trends and report the results. To learn about the current treatment therapy for advanced BC patients in different areas in China.To provide references for standardized treatment therapy, to improve the quality of patients' life and to prolong the survival time for the advanced BC patients.To assess the different treatment therapies for advanced BC with consideration of economic cost-effectiveness

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

4,200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard therapy	Drug	standard therapy for advanced/metastatic breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival status at 3 years	percentage of patients still alive at 3 years	3 years

Secondary Outcomes

Measure	Description	Time Frame
PFS	Progression-free survival of first line therapy	3 years
Survival status at 5 years	percentage of patients still alive at 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed as advanced breast cancer during Jan1st,2012-Dec31st,2014
complete with surgical pathology data, auxiliary treatment, there is a clear recurrence, transfer time, place, transfer of recurrence after treatment, and curative effect evaluation details.In any age, ethnic group cases.

Exclusion Criteria:

no available medical record

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

A total of 21 hospitals were selected in this study. The investigators recruited 4200 advanced BC cases, who were first diagnosed with advanced BC from January 1st, 2012 to December 31st, 2014 from these hospitals.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Binghe Xu	Contact			syhiir@126.com

Overall Officials

Name	Affiliation	Role
Binghe Xu	Chinese Academy of Medical Sciences	Principal Investigator
Youlin Qiao	Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The 307th Hospital of Military Medical Sciences	Not yet recruiting	Beijing			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34567118	Derived	Han YQ, Yi ZB, Yu P, Wang WN, Ouyang QC, Yan M, Wang XJ, Hu XC, Jiang ZF, Huang T, Tong ZS, Wang SS, Yin YM, Li H, Yang RX, Yang HW, Teng YE, Sun T, Cai L, Li HY, Ouyang XN, He JJ, Liu XL, Yang SE, Qiao YL, Fan JH, Wang JY, Xu BH. Comparisons of Treatment for HER2-Positive Breast Cancer between Chinese and International Practice: A Nationwide Multicenter Epidemiological Study from China. J Oncol. 2021 Sep 15;2021:6621722. doi: 10.1155/2021/6621722. eCollection 2021.
34472719

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation