Clinical trial NCT05247164: EUS-guided PORtal Vein Sampling for Circulating Tumor Cells in Pancreatic Cancer Patients
Official title: EUS-guided PORtal Vein Sampling for Isolation, Enumeration and Profiling of Circulating Tumor Cells in Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Adenocarcinoma
Keywords: Endoscopic Ultrasound
EUS
Portal blood
Circulating Tumor Cells
Fine Needle Aspiration
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with successful aspiration of portal blood
timeFrame: Day 1
measure: Proportion of patients with procedure-related Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Difference between Portal and Peripheral CTC concentration
timeFrame: Day 1
measure: Portal CTC concentration according to clinical stage
timeFrame: Day 1
measure: Baseline portal CTC concentration in patients with progressive versus non-progressive diseases
timeFrame: 24 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Giuseppe Vanella
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.