Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System

Healthy Volunteers Clinical Trial

— HOMING  

Official title:

Harvest of Circulating Tumor Cells (CTCs) From Patients With Metastatic Breast Cancer (MBC) Using the Parsortix™ PC1 System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427450
• Other study ID #: ANG-002
• Status: Completed
• Start date: March 29, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2023
• Source: Angle plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 evaluable healthy volunteer (HV) subjects (healthy women with no history of cancer) will be enrolled at a minimum of three (3) US based clinical sites. Each subject will have information about their age race/ethnicity, height and weight, menopausal status, smoking status, pregnancy and/or nursing status, and a brief medical history captured at the time of enrollment. Blood will be drawn from each subject into three different EDTA tubes (minimum of ~7mL up to a maximum of ~23mL of whole blood) specifically for the purposes of this study. One of the blood tubes collected will be used for a complete blood count (CBC) with differential testing, while the other two tubes of blood will be processed on the Parsortix PC1 system for the capture and harvest of CTCs. The cells harvested from one of the blood tubes will be deposited onto a glass slide and automated Wright-Giemsa staining will be done to allow for identification of CTCs based on their cytologic features (e.g. size, shape, nuclear to cytoplasmic ratio, chromatin structure, etc.) by an expert cytopathologist. The cells harvested from the remaining blood tube will be used for one of three different evaluations: Fluorescence in-situ hybridization (FISH) for evaluation of Her-2/neu gene amplification, quantitative reverse-transcriptase real-time PCR (qRT-PCR) for evaluation of cancer related gene expression, or whole transcriptome sequencing (RNAseq) for determination of the expression patterns of breast cancer related genes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: December 31, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer, Metastatic
• Breast Neoplasms
• Healthy Volunteers

Intervention

Diagnostic Test:
• Blood draw
Blood collected will be processed on Parsortix PC1 system for capture and harvest of circulating tumor cells to be used in subsequent evaluations.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	University of Rochester Medical Center Wilmot Cancer Institute	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Angle plc

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cohen EN, Jayachandran G, Moore RG, Cristofanilli M, Lang JE, Khoury JD, Press MF, Kim KK, Khazan N, Zhang Q, Zhang Y, Kaur P, Guzman R, Miller MC, Reuben JM, Ueno NT. A Multi-Center Clinical Study to Harvest and Characterize Circulating Tumor Cells from — View Citation

Hvichia GE, Parveen Z, Wagner C, Janning M, Quidde J, Stein A, Muller V, Loges S, Neves RP, Stoecklein NH, Wikman H, Riethdorf S, Pantel K, Gorges TM. A novel microfluidic platform for size and deformability based separation and the subsequent molecular characterization of viable circulating tumor cells. Int J Cancer. 2016 Jun 15;138(12):2894-904. doi: 10.1002/ijc.30007. Epub 2016 Feb 26. — View Citation

Xu L, Mao X, Imrali A, Syed F, Mutsvangwa K, Berney D, Cathcart P, Hines J, Shamash J, Lu YJ. Optimization and Evaluation of a Novel Size Based Circulating Tumor Cell Isolation System. PLoS One. 2015 Sep 23;10(9):e0138032. doi: 10.1371/journal.pone.0138032. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Her2 FISH Evaluation	Demonstrate that CTCs harvested from peripheral blood of MBC patients by the Parsortix PC1 system and deposited onto slides can be evaluated by fluorescence in-situ hybridization (FISH) for Her-2/neu gene amplification.	1 day (At time of blood draw)
Other	qPCR Evaluation	Demonstrate that CTCs harvested from peripheral blood of MBC patients by the Parsortix PC1 system and deposited into an RNA preservation/lysis buffer can be evaluated using qPCR for analysis of cancer related gene expression.	1 day (At time of blood draw)
Other	RNAseq Evaluation	Demonstrate that CTCs harvested from peripheral blood of MBC patients by the Parsortix PC1 system and deposited into an RNA preservation/lysis buffer can be evaluated using whole genome sequencing (RNAseq) for determination of the expression patterns of breast cancer related genes.	1 day (At time of blood draw)
Primary	Incidence of CTC	Determine the proportion of MBC patients and healthy volunteers (HVs or controls) that have one or more observable CTCs (as determined by a qualified pathologist using cytological evaluation of Wright-Giemsa stained slides) harvested from their peripheral blood using the Parsortix PC1 system.	1 day (At time of blood draw)
Secondary	CTC Enumeration	Quantify the number of observable CTCs (as determined by a qualified pathologist using cytological evaluation of Wright-Giemsa stained slides) harvested from the peripheral blood of each MBC patient and healthy volunteer (HV or control) and summarize separately for each group.	1 day (At time of blood draw)