The Study on the Clinical Utility of Liquid Biopsy in Breast Cancer

September 12, 2016 updated by: Fei Ma, Peking Union Medical College
Through this prospective clinical trial,the investigators will focus on the relationship between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and other biomarkers) and the status of primary tumor to discuss its application for assessing prognosis and individualized therapeutic direction. Moreover, the relationship between the circulating tumor cell subpopulations based on epithelial-mesenchymal transition and molecular pathological classification of breast cancer will be determined, which may enable the determination of the value of its application in therapeutic decision making.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time.

Description

Inclusion Criteria:

  • Female patients aged ≥18 years with histologically confirmed breast cancer.
  • The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time.

Exclusion Criteria:

  • The patients who has begun medication for breast cancer.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the enumeration of circulating tumor biomarkers
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

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

Sponsor

Peking Union Medical College

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

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-BC-052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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