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

April 27, 2018 updated by: CellMaxLife
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

210

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 Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Medical University Hospital
        • Contact:
          • Ming-Feng Hou

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer patients

Description

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

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

Cohorts and Interventions

Group / Cohort
Control Group
Mammography/ultrasonography confirmed no findings.
Cancer Group
The biopsy result is breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects.
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

CellMaxLife

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 (ACTUAL)

November 16, 2017

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (ACTUAL)

April 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMx-CTC-BC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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