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Trial record 7 of 169 for:    breast,cancer,detection | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03511859
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
CellMaxLife

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.

Condition or disease
Breast Cancer

Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  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. [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Breast cancer patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511859


Contacts
Contact: Joy Chang +886-2-26558455 joy@cellmaxlife.com

Locations
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan
Contact: Ming-Feng Hou         
Sponsors and Collaborators
CellMaxLife

Responsible Party: CellMaxLife
ClinicalTrials.gov Identifier: NCT03511859     History of Changes
Other Study ID Numbers: CMx-CTC-BC-001
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CellMaxLife:
Breast cancer. Circulating tumor cells. CTCs. Cell free DNA. cfDNA

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes