Silicon Microsieve Device vs Cell Surface Marker-based Platform for the Isolation of Pancreatic Cancer CTCs

November 19, 2020 updated by: Singapore General Hospital

A Head-to-head Comparison of a Novel Silicon Microsieve Device Against a Cell Surface Marker-based Platform for the Isolation of Portal Vein Circulating Tumor Cells in Pancreatic Cancer

The study aims to compare the use of a microsieve device vs a cell surface marker-based platform for the isolation of pancreatic cancer circulating tumor cells

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Circulating tumor cells (CTCs) aid prognostication of cancer by predicting the presence of microscopic metastases. This is important in pancreatic cancer, which is associated with a poor prognosis even in resectable disease, due to microscopic metastases that are not detectable on pre-operative cross-sectional imaging. In pancreatic cancer, blood is sampled from the portal circulation to overcome the "hepatic sieve" effect, where CTCs are filtered out in the capillary beds of the liver before entering the peripheral circulation. Minimally invasive blood sampling from the portal vein can now be done via endoscopic ultrasound (EUS) guidance, allowing CTC analyses to be done pre-operatively.

CTCs have traditionally been isolated in various cancers using a cell surface marker-based platform (CellSearch™). This involves the use of antibodies to identify, isolate and quantify CTCs based on presence of specific epithelial cell markers. However, CTCs are now known to undergo epithelial-mesenchymal transformation. The current epithelial cell surface marker-based method of CTC isolation is limited by its inability to detect mesenchymal-type CTCs, potentially under estimating the CTC count, affecting quantification and subsequent CTC molecular analyses.

The use of a novel silicon microsieve device will overcome these limitations. It will simplify the isolation of CTCs by its characteristic size, enable both epithelial and mesenchymal types of CTCs to be isolated and results in greater cell viability, aiding in subsequent cell culture and organoid growth.

The investigators will compare a novel silicon microsieve size-based cell filtration device against the cell surface marker label-based CellSearch™ platform for the identification of pancreatic cancer CTCs in portal venous blood obtained via an Endoscopic Ultrasound (EUS)-guided puncture. The investigators will compare the yield of epithelial-type CTCs isolated using both methods. The investigators will investigate whether the isolation of mesenchymal-type CTCs via a sized-based cell filtration device leads to a significant increase in total CTC yield.

The investigators expect our study to show that the new technique of size-based CTC isolation improves CTC yield in pancreatic cancer. This preliminary data would be crucial for future research into patient selection for neoadjuvant chemotherapy and individualized treatment from patient-specific tumor tissue, which the investigators intend to embark upon.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 21 years and older
  2. All inpatients with solid pancreatic lesions referred for Endoscopic Ultrasound - Fine Needle Aspiration (EUS-FNA)
  3. Solid lesions confirmed by at least a single investigational modality, mainly CT, MRI or endoscopy
  4. Able to comply with the study procedure and provide informed consent.

Exclusion Criteria:

  1. Presence of active bleeding
  2. Presence of coagulopathy as evidenced by INR >1.5 and platelets <50,000
  3. Poor patient tolerance to procedure
  4. Concurrent intake of anticoagulants and thienopyridine (e.g.Clopidogrel) in patients who require antiplatelet therapy
  5. Pregnancy
  6. Presence of portal vein thrombus
  7. Patients with liver cirrhosis and /or other structural abnormalities in the liver or the stomach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Isolation of circulating tumor cells
Both portal venous and peripheral blood will be obtained from the patient and subjected to analysis for pancreatic cancer circulating tumor cells
Device: Microsieve device
Both portal venous and peripheral blood will be processed through a label-free size-based silicon microsieve microfiltration device, which will isolate both epithelial-type and mesenchymal-type pancreatic cancer circulating tumor cells. Downstream mutational analyses will be performed to confirm identity of the cells.
Device: Cell surface marker-based platform
Both portal venous and peripheral blood will be processed through a cell surface marker-based platform, which contains antibodies for epithelial cell markers on pancreatic cancer circulating tumor cells. Downstream mutational analyses will be performed to confirm identity of the cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of circulating tumor cells
Time Frame: Immediately following procedure
The number of circulating tumor cells isolated via both methods (microsieve device and cell surface marker-based platform)
Immediately following procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

Agency for Science, Technology and Research

Investigators

  • Principal Investigator: Damien Meng Yew Tan, MBBS, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 17, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (ACTUAL)

November 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2502
  • 03/FY2018/P1/13-A28FY2019PFF02 (OTHER_GRANT: Singapore General Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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