A Nation-wide Multicenter Clinical Epidemiologic Study of Chinese Females With Advanced Breast

February 7, 2017 updated by: Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • The 307th Hospital of Military Medical Sciences
        • Contact:
          • Zefei Jiang
      • Chengdu, China
        • Not yet recruiting
        • Sichuan Cancer Hospital and Institute
        • Contact:
          • Hui Li
      • Chongqing, China
        • Not yet recruiting
        • The First Affliated Hospital of Chongqing Medical University
        • Contact:
          • Hongyuan Li
      • Fuzhou, China
        • Not yet recruiting
        • FuZhou General Hospital of National Miltary Command
        • Contact:
          • Xuenong Ouyang
      • Guangzhou, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Shuseng Wang
      • Harbin, China
        • Not yet recruiting
        • Harbin medical university cancer hospital
      • Henan, China
        • Not yet recruiting
        • Henan Cancer Hospital
      • Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital
      • Jiangsu, China
        • Not yet recruiting
        • Jiangsu Provinces hospital
        • Contact:
          • Yongmei Yin
      • Kunming, China
        • Not yet recruiting
        • Tumor Hospital of Yunnan Province
      • Liaoning, China
        • Not yet recruiting
        • Liaoning Cancer Hospital, Zhejiang Cancer Hospital
      • Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Xinlan Liu
      • Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
      • Shenyang, China
        • Not yet recruiting
        • The First Hospital of China Medical University
      • Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
      • Wuhan, China
        • Not yet recruiting
        • Wuhan Union Hospital
        • Contact:
          • Tao Huang
      • Xi'an, China
        • Not yet recruiting
        • The First Hospital of Xi'an Jiaotong University
        • Contact:
          • Jianjun He
      • Xinjiang, China
        • Not yet recruiting
        • Xinjiang Medical University Cancer Hospital
        • Contact:
          • Shune Yang
      • Zhengzhou, China
        • Not yet recruiting
        • Fujian Provincial Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival status at 3 years
Time Frame: 3 years
percentage of patients still alive at 3 years
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 3 years
Progression-free survival of first line therapy
3 years
Survival status at 5 years
Time Frame: 3 years
percentage of patients still alive at 5 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Youlin Qiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CH-BC-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Breast Cancer

Clinical Trials on standard therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings