Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System (NCT03427450) | Clinical Trial Compass
CompletedNot Applicable
Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System
United States421 participantsStarted 2018-03-29
Plain-language 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 metastatic breast cancer (MBC) and not from healthy volunteers (HVs). The study is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC patients can be used effectively for different types of evaluations (e.g. cytopathology, FISH, qPCR, RNAseq, etc.).
This is an investigational study. The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only.
Who can participate
Age range22 Years
SexFEMALE
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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 …