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Healthy VolunteersHOMINGNCT03427450

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

An observational study of Healthy Volunteers and Breast Cancer, Metastatic, run by Angle plc at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 22 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Breast Cancer, Metastatic
What is being tested?
Blood draw
How many people
421 participants
Where
4 sitesUnited States
Study dates
29 Mar 2018to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Southern California

    Los Angeles, California, 90033

  • University of Rochester Medical Center Wilmot Cancer Institute

    Rochester, New York, 14642

Other trials in United States

About this study

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

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.

Read the 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 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.

Being tested
Blood draw
Keywords
circulating tumor cells, liquid biopsy, microfluidics
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood drawDiagnostic test

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

Study groups in NCT03427450
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Diagnostic Test: Blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day (At time of blood draw)

Secondary outcomes (1)

  1. 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.

    Measured: 1 day (At time of blood draw)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2018
  2. Study start29 Mar 2018
  3. Primary completion16 May 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03427450
Sponsor's protocol ID
ANG-002
Acronym
HOMING
Status last verified
Jun 2023
First submitted
31 Jan 2018
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 26397728

  • 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.

    PubMed 26789903

  • 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.

    PubMed 36358657

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers and Breast Cancer, Metastatic, run by Angle plc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of CTC (time frame: 1 day (At time of blood draw)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03427450, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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