Silicon Microsieve Device vs Cell Surface Marker-based Platform for the Isolation of Pancreatic Cancer CTCs
NCT ID: NCT04638868
Last Updated: 2020-11-23
Study Results
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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UNKNOWN
NA
26 participants
INTERVENTIONAL
2020-11-17
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Agency for Science, Technology and Research
OTHER
Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Damien Meng Yew Tan, MBBS
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Central Contacts
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References
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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.
Tien 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.
Catenacci 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.
Christiansen 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.
Cima 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.
Other Identifiers
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03/FY2018/P1/13-A28FY2019PFF02
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2019/2502
Identifier Type: -
Identifier Source: org_study_id