Clinical trial · Interventional

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

NCT04638868CI-TRIAL-00048445unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Cell surface marker-based platform	Device	—	UNRESOLVED
Microsieve device	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Isolation of circulating tumor cells
description
Both portal venous and peripheral blood will be obtained from the patient and subjected to analysis for pancreatic cancer circulating tumor cells
interventionNames
1. Device: Microsieve device
2. Device: Cell surface marker-based platform

Primary outcomes (1)

measure
Number of circulating tumor cells
timeFrame
Immediately following procedure
description
The number of circulating tumor cells isolated via both methods (microsieve device and cell surface marker-based platform)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 21 Years

Show eligibility criteria text

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

References

Publications (5)

BACKGROUNDChapman 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 30117486
RESULTTien 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 27100430
RESULTCatenacci 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 26341722
RESULTChristiansen 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 16951136
RESULTCima 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 24403992