Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-16

Study Completion Date

2019-12-31

Brief Summary

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Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for cancer management throughout the course of the disease.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast cancer. Circulating tumor cells. CTCs. Cell free DNA. cfDNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Mammography/ultrasonography confirmed no findings.

No interventions assigned to this group

Cancer Group

The biopsy result is breast cancer.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All subjects need to sign the informed consent form and age is above 20.
* Control group need to have mammogram /ultrasound results category1-3 and confirmed by PI.
* Cancer group subjects with pathology report confirmed to be malignant have not yet done surgery or treatment will be enrolled to the malignant group for analysis

Exclusion Criteria

* Not willing to sign the informed consent form
* Have been undergone general anesthesia or regional anesthesia in 1 month
* Have been diagnosed with any type of cancer and been treated
* Have been suffering from autoimmune disorder such as SLE and RA
* Have been suffering from chronic infection such as IBD, pancreatitis, COPD or Interstitial pneumonia.
* Have been suffering from acute infection or other infectious diseases in 3 moths such as TB, pneumonia, urinary tract infection, or cellular infection
* Diagnosed with myelodysplastic syndrome or myeloproliferative diseases
* Other condition which may affect the CTC results, when determined by PI can be confirmed by other tests are if necessary

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Joy Chang

Role: CONTACT

Phone: +886-2-26558455

Email: [email protected]

Facility Contacts

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Ming-Feng Hou

Role: primary

Other Identifiers

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CMx-CTC-BC-001

Identifier Type: -

Identifier Source: org_study_id