NCT02902991

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 4, 2016

Last Update Submit

September 12, 2016

Conditions

Breast Cancer

Keywords

liquid biopsy, breast cancer,circulating tumor biomarker

Outcome Measures

Primary Outcomes (1)

  • the enumeration of circulating tumor biomarkers

    up to 2 years

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • The patients who has begun medication for breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor cells,circulating tumor DNA and other liquid biopsy biomarkers

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing,China

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 16, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

September 16, 2016

Record last verified: 2016-09