Status:
COMPLETED
Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System
Lead Sponsor:
Angle plc
Conditions:
Healthy Volunteers
Breast Cancer, Metastatic
Eligibility:
FEMALE
22+ years
Brief Summary
The purpose of this clinical study is to demonstrate that the Parsortix™ PC1 system enables the capture and harvest of circulating tumor cells (CTCs) from the peripheral blood of patients with metasta...
Detailed Description
Approximately 200 evaluable MBC patients (either newly diagnosed or patients with progressive/recurrent disease who are about to start a new line of therapy for the treatment of their disease) and 200...
Eligibility Criteria
Inclusion
- MBC Patient Inclusion Criteria
- Female \>=22 years of age;
- Documented evidence of metastatic breast cancer (i.e. primary tumor histopathology of breast cancer and documented evidence of distant sites of metastasis by imaging, biopsy, or other means) that is either newly diagnosed or currently progressing / recurrent (disease progression / recurrence may be determined by any means, including RECIST v1.1 criteria, physical signs and symptoms, rising tumor markers, physician determination, etc.);
- If newly diagnosed, have not yet started a new line of therapy of any type (e.g. hormonal, cytotoxic, targeted, etc.) for the treatment and/or management of their metastatic breast cancer;
- If progressing or recurrent, any number of prior hormonal therapies, chemotherapies and/or biological/targeted therapies are allowed;
- Willing and able to provide informed consent and agree to complete all aspects of the study.
- MBC Patient Exclusion Criteria
- Female subjects \<=21 years old or male subjects;
- Concurrent other malignancies (except for a second primary breast cancer);
- Less than seven days since last administration of a cytotoxic agent;
- Unwilling or unable to provide informed consent or high risk that subject may not comply with protocol requirements.
- HV Inclusion Criteria
- Females \>=22 years of age;
- No known fever or active infections at the time of the blood collection;
- No known current diagnosis of acute inflammatory disease or chronic inflammation;
- No known current and/or prior history of malignancy, excluding skin cancers (squamous cell or basal cell);
- Willing and able to provide informed consent and agree to complete all aspects of the study.
- HV Exclusion Criteria
- Female subjects \<=21 years old or male subjects;
- Known illness at the time of the blood collection;
- Known current and/or prior history of malignancy, excluding skin cancers (squamous cell or basal cell);
- Unwilling or unable to provide informed consent or high risk that subject may not comply with protocol requirements (e.g. due to health and/or participation in other research studies).
Exclusion
Key Trial Info
Start Date :
March 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT03427450
Start Date
March 29 2018
End Date
December 31 2019
Last Update
June 5 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California
Los Angeles, California, United States, 90033
2
Northwestern University
Chicago, Illinois, United States, 60611
3
University of Rochester Medical Center Wilmot Cancer Institute
Rochester, New York, United States, 14642
4
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030