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

NCT03427450 | Completed FDA Device

• 1 other identifier: ANG-002
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Healthy Volunteers; Breast Cancer, Metastatic

Keywords

circulating tumor cells; liquid biopsy; microfluidics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CTC Enumeration

  1 day (At time of blood draw)

Other Outcomes (3)

• Her2 FISH Evaluation

  1 day (At time of blood draw)

• qPCR Evaluation

  1 day (At time of blood draw)

• RNAseq Evaluation

  1 day (At time of blood draw)

Study Arms (2)

Healthy Volunteers (Controls)

A control population of healthy volunteers (HVs) consisting of women with no prior/current history of cancer and no known history of breast disease (the information obtained from the HVs may be 'self-reports', as complete medical records may not be available at the enrolling site for these control subjects), and with a broadly similar age range to the cancer patient study population. All eligible and consenting subjects will have blood draw.

Diagnostic Test: Blood draw

MBC Patients (Cancers)

Women with either newly diagnosed metastatic breast cancer who are about to start a new line of therapy of any type for the treatment and/or management of their disease or those with currently progressive or recurrent disease (as determined by any means) will be eligible for enrollment into the cancer population. All eligible and consenting subjects will have blood draw.

Diagnostic Test: Blood draw

Interventions

Blood draw DIAGNOSTIC_TEST

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

Healthy Volunteers (Controls); MBC Patients (Cancers)

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers: Female subjects at outpatient clinics whom a delegated physician and/or study coordinator believe may be eligible for the study will be approached by the delegated physician and/or study coordinator during their scheduled gynecology appointment or, if they are accompanying a breast cancer patient, during the scheduled appointment of the individual they are accompanying. Metastatic Breast Cancer Patients: Eligible female subjects at outpatient clinics and/or under the care of investigators at the participating medical centers will be prospectively identified by the site principal investigator, sub-investigators, nurses and/or study coordinator.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Angle plc: lead

Study Sites (4)

University of Southern California

Los Angeles, California, 90033, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Rochester Medical Center Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 26397728 BACKGROUND

• 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.

  PMID: 26789903 BACKGROUND

• 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 Patients with Metastatic Breast Cancer Using the Parsortix(R) PC1 System. Cancers (Basel). 2022 Oct 26;14(21):5238. doi: 10.3390/cancers14215238.

  PMID: 36358657 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Cytology slides Her2 FISH slides mRNA cDNA

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Naoto Ueno, MD, PhD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 9, 2018
• Study Start: March 29, 2018
• Primary Completion: May 16, 2019
• Study Completion: December 31, 2019
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)