Silicon Microsieve Device vs Cell Surface Marker-based Platform for the Isolation of Pancreatic Cancer CTCs
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
2 other identifiers
interventional
26
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Nov 2020
Shorter than P25 for not_applicable pancreatic-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedStudy Start
First participant enrolled
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 23, 2020
November 1, 2020
1.1 years
November 16, 2020
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of circulating tumor cells
The number of circulating tumor cells isolated via both methods (microsieve device and cell surface marker-based platform)
Immediately following procedure
Study Arms (1)
Isolation of circulating tumor cells
EXPERIMENTALBoth portal venous and peripheral blood will be obtained from the patient and subjected to analysis for pancreatic cancer circulating tumor cells
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 21 years and older
- All inpatients with solid pancreatic lesions referred for Endoscopic Ultrasound - Fine Needle Aspiration (EUS-FNA)
- Solid lesions confirmed by at least a single investigational modality, mainly CT, MRI or endoscopy
- Able to comply with the study procedure and provide informed consent.
You may not qualify if:
- Presence of active bleeding
- Presence of coagulopathy as evidenced by INR \>1.5 and platelets \<50,000
- Poor patient tolerance to procedure
- Concurrent intake of anticoagulants and thienopyridine (e.g.Clopidogrel) in patients who require antiplatelet therapy
- Pregnancy
- Presence of portal vein thrombus
- Patients with liver cirrhosis and /or other structural abnormalities in the liver or the stomach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Chapman CG, Waxman I. EUS-guided portal vein sampling. Endosc Ultrasound. 2018 Jul-Aug;7(4):240-245. doi: 10.4103/eus.eus_28_18.
PMID: 30117486BACKGROUNDTien YW, Kuo HC, Ho BI, Chang MC, Chang YT, Cheng MF, Chen HL, Liang TY, Wang CF, Huang CY, Shew JY, Chang YC, Lee EY, Lee WH. A High Circulating Tumor Cell Count in Portal Vein Predicts Liver Metastasis From Periampullary or Pancreatic Cancer: A High Portal Venous CTC Count Predicts Liver Metastases. Medicine (Baltimore). 2016 Apr;95(16):e3407. doi: 10.1097/MD.0000000000003407.
PMID: 27100430RESULTCatenacci DV, Chapman CG, Xu P, Koons A, Konda VJ, Siddiqui UD, Waxman I. Acquisition of Portal Venous Circulating Tumor Cells From Patients With Pancreaticobiliary Cancers by Endoscopic Ultrasound. Gastroenterology. 2015 Dec;149(7):1794-1803.e4. doi: 10.1053/j.gastro.2015.08.050. Epub 2015 Sep 2.
PMID: 26341722RESULTChristiansen JJ, Rajasekaran AK. Reassessing epithelial to mesenchymal transition as a prerequisite for carcinoma invasion and metastasis. Cancer Res. 2006 Sep 1;66(17):8319-26. doi: 10.1158/0008-5472.CAN-06-0410.
PMID: 16951136RESULTCima I, Wen Yee C, Iliescu FS, Phyo WM, Lim KH, Iliescu C, Tan MH. Label-free isolation of circulating tumor cells in microfluidic devices: Current research and perspectives. Biomicrofluidics. 2013 Jan 24;7(1):11810. doi: 10.1063/1.4780062. eCollection 2013.
PMID: 24403992RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damien Meng Yew Tan, MBBS
Singapore General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 20, 2020
Study Start
November 17, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
November 23, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share