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2022-05-17
2025-10
2027-03
70
NCT05247164
IRCCS San Raffaele
IRCCS San Raffaele
INTERVENTIONAL
EUS-guided PORtal Vein Sampling for Circulating Tumor Cells in Pancreatic Cancer Patients
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-02-06 | N/A | 2025-04-29 |
2022-02-15 | N/A | 2025-05-01 |
2022-02-18 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: PDAC Patients Patients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling. | PROCEDURE: EUS-guided Portal Vein sampling
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Difference between Portal and Peripheral CTC concentration | CTC concentration [Count / 7.5 ml of blood] | Day 1 |
| Portal CTC concentration according to clinical stage | CTC concentration [Count / 7.5 ml of blood] | Day 1 |
| Baseline portal CTC concentration in patients with progressive versus non-progressive diseases | CTC concentration [Count / 7.5 ml of blood] | 24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
