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Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood

NCT ID: NCT03058809

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-05-31

Brief Summary

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This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.

Detailed Description

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Conditions

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Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects will be their own controls
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metastatic Breast, Colon and Prostate Cancer

Metastatic breast, colon or prostate cancer patients will have their CTC levels determined on 3 days before treatment with the Viatar Oncopheresis System to establish a baseline value, a pretreatment value, a post treatment value and on 4 additional instances over a period of 7 days post treatment to establish a CTC rebound profile using a validated CTC enumeration system.

Group Type EXPERIMENTAL

Oncopheresis

Intervention Type DEVICE

Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.

Interventions

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Oncopheresis

Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of breast, colon or prostate cancer
* No prior cancer therapy or failed first line therapy
* \>= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment
* \> 1 month life expectancy
* Adequate baseline hematological function as assessed by the following laboratory values:

* Hemoglobin \> 9 g/dl
* Platelets \> 100,000/mm3
* WBC \> 3,000/mm3
* Absolute Neutrophil Count \> 1,500/mm3

Exclusion Criteria

* Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism
* Patients with known immunodeficiency virus (HIV)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viatar LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nigel Murray, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Carabineros

Central Contacts

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Michael A Patz

Role: CONTACT

Phone: 9787128210

Email: [email protected]

Steve Keaney

Role: CONTACT

Other Identifiers

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T30-0002

Identifier Type: -

Identifier Source: org_study_id