EUS-guided PORtal Vein Sampling for Circulating Tumor Cells in Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

— EUPhORIC  

Official title:

EUS-guided PORtal Vein Sampling for Isolation, Enumeration and Profiling of Circulating Tumor Cells in Pancreatic Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247164
• Other study ID #: 129/INT/2021
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: March 2027

Study information

• Verified date: October 2023
• Source: IRCCS San Raffaele
• Contact: Giuseppe Vanella
• Phone: +390226439574
• Email: vanella.giuseppe[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims at evaluating the feasibility and safety of EUS-guided Portal Circulation sampling for isolation, enumeration and profiling od Circulating Tumor Cells (CTC) in Pancreatic Cancer patients.

Patients undergoing Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia will receive an additional Fine Needle Aspiration sampling of a branch of the Portal Circulation to obtain a blood sample which will be processed for CTC enrichment, count and characterization.

Description:

Prognostic stratification of patients with Pancreatic Ductal Adenocarcinoma (PDAC) is still suboptimal, relying only on imaging studies and Carbohydrate Antigen 19.9 to drive important treatment decisions (e.g. surgery versus neoadjuvant chemotherapy).

Circulating Tumor Cells (CTCs) have been poorly evaluated in this neoplasia as they are rarely detected in the peripheral blood, whereas they are more abundantly detected in the portal circulation below the hepatic filter.

Most PDAC patients undergo Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia. EUS-guided acquisition of portal blood for CTC evaluation has demonstrated its feasibility in preliminary studies without reducing the safety of the endoscopic procedure.

The study aims at collecting portal blood from PDAC patients under EUS-guidance to evaluate whether concentration and characterization of CTCs has a prognostic significance and can aid in decision making.

A paired peripheral blood sample will be acquired for comparison. Samples will be processed to obtain microfluidic enrichment of CTCs and stained with immunofluorescent antibodies for exclusion of hematopoietic cells and specific identification of CTCs, which will then be counted to obtain the blood concentration expressed as number of cells per 7.5 ml of blood.

Patients will be followed every 60 days for a maximum of 24 months to assess the evolution of primary disease and clinical status.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient with a pancreatic solid lesion undergoing EUS with a rapid on-site confirmation of a pancreatic ductal adenocarcinoma

• patients primarily followed within San Raffaele Institute

Exclusion Criteria:

• history of active non-pancreatic cancer

• coagulopathy (INR > 1.5; platelets < 70.000/ul) or use of non-withdrawable anticoagulant or antiplatelet

• known history or endosonographic signs of portal hypertension

• extensive invasion of portal vein precluding needle maneuvers

• pregnancy and breastfeeding

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• EUS-guided Portal Vein sampling
Transgastric and Transhepatic Fine Needle Aspiration of a branch of the Portal Vein under EUS guidance. A paired peripheral sample will be acquired.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

Liu X, Li C, Li J, Yu T, Zhou G, Cheng J, Li G, Zhou Y, Lou W, Wang X, Gong G, Liu L, Chen Y. Detection of CTCs in portal vein was associated with intrahepatic metastases and prognosis in patients with advanced pancreatic cancer. J Cancer. 2018 May 22;9(11):2038-2045. doi: 10.7150/jca.23989. eCollection 2018. — View Citation

Pang TCY, Po JW, Becker TM, Goldstein D, Pirola RC, Wilson JS, Apte MV. Circulating tumour cells in pancreatic cancer: A systematic review and meta-analysis of clinicopathological implications. Pancreatology. 2021 Jan;21(1):103-114. doi: 10.1016/j.pan.2020.11.022. Epub 2020 Dec 3. — View Citation

Zhang Y, Su H, Wang H, Xu C, Zhou S, Zhao J, Shen S, Xu G, Wang L, Zou X, Zhang S, Lv Y. Endoscopic Ultrasound-Guided Acquisition of Portal Venous Circulating Tumor Cells as a Potential Diagnostic and Prognostic Tool for Pancreatic Cancer. Cancer Manag Res. 2021 Oct 5;13:7649-7661. doi: 10.2147/CMAR.S330473. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with successful aspiration of portal blood	The proportion of patients with successful needle access to the portal circulation with subsequent successful aspiration of portal blood	Day 1
Primary	Proportion of patients with procedure-related Adverse Events	The proportion of patients experiencing procedure-related adverse events, such as bleeding or perihepatic collections.	30 days
Secondary	Difference between Portal and Peripheral CTC concentration	CTC concentration [Count / 7.5 ml of blood]	Day 1
Secondary	Portal CTC concentration according to clinical stage	CTC concentration [Count / 7.5 ml of blood]	Day 1
Secondary	Baseline portal CTC concentration in patients with progressive versus non-progressive diseases	CTC concentration [Count / 7.5 ml of blood]	24 months