Pancreatic CancerNCT04638868
Silicon Microsieve Device vs Cell Surface Marker-based Platform for the Isolation of Pancreatic Cancer CTCs
A study testing Microsieve device and Cell surface marker-based platform in people with Pancreatic Cancer, run by Singapore General Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Microsieve device and Cell surface marker-based platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Microsieve device, Cell surface marker-based platform
- Keywords
- Circulating Tumor Cells, Endoscopic Ultrasound, Portal vein blood sampling, Fine needle aspiration, Microsieve
- Medical subject headings
- Pancreatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsieve deviceDevice
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 platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Isolation of circulating tumor cells | Experimental | Both portal venous and peripheral blood will be obtained from the patient and subjected to analysis for pancreatic cancer circulating tumor cells Receives: Device: Microsieve device; Device: Cell surface marker-based platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating tumor cells
The number of circulating tumor cells isolated via both methods (microsieve device and cell surface marker-based platform)
Measured: Immediately following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start17 Nov 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Sponsor
- Investigators
- Damien Meng Yew Tan, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638868
- Sponsor's protocol ID
- 2019/2502
- Other IDs
- 03/FY2018/P1/13-A28FY2019PFF02
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30117486Tien 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.
PubMed 27100430Catenacci 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.
PubMed 26341722Christiansen 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.
PubMed 16951136Cima 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.
PubMed 24403992
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04638868
- Acronym / sponsor ID
- 2019/2502
- Conditions
- Pancreatic Cancer
- Keywords
- Circulating Tumor Cells, Endoscopic Ultrasound, Portal vein blood sampling, Fine needle aspiration, Microsieve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 17 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolation of circulating tumor cells | Experimental | Device: Microsieve device, Device: Cell surface marker-based platformBoth portal venous and peripheral blood will be obtained from the patient and subjected to analysis for pancreatic cancer circulating tumor cells |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsieve deviceBoth 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 | Isolation of circulating tumor cells |
| Cell surface marker-based platformBoth 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. | Device | Isolation of circulating tumor cells |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Background: PubMed 30117486Chapman CG, Waxman I. EUS-guided portal vein sampling. Endosc Ultrasound. 2018 Jul-Aug;7(4):240-245. doi: 10.4103/eus.eus_28_18.
- Results publication: PubMed 27100430Tien 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.
- Results publication: PubMed 26341722Catenacci 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.
- Results publication: PubMed 16951136Christiansen 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.
- Results publication: PubMed 24403992Cima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien Meng Yew Tan, MBBS principal investigator
Singapore General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Microsieve device and Cell surface marker-based platform in people with Pancreatic Cancer, run by Singapore General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Meng Yew Tan, MBBS (+6582995594, damien.tan.m.y@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating tumor cells (time frame: Immediately following procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638868, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.