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
1 other identifier
observational
210
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2017
CompletedFirst Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 30, 2018
April 1, 2018
1.1 years
April 17, 2018
April 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Study Arms (2)
Control Group
Mammography/ultrasonography confirmed no findings.
Cancer Group
The biopsy result is breast cancer.
Eligibility Criteria
Breast cancer patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CellMaxLifelead
Study Sites (1)
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2018
First Posted
April 30, 2018
Study Start
November 16, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2019
Last Updated
April 30, 2018
Record last verified: 2018-04