Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level (EUS-CTC)

Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care

The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.

Study Overview

• Status: Recruiting
• Conditions: Cancer of Pancreas
• Intervention / Treatment: Procedure: Blood sample in portal vein

Detailed Description

The study will include 42 evaluable patients suspected of having pancreatic cancer and for whom an echo-endoscopic biopsy (EUS-FNA) and/or biliary drainage is planned.

In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:

• the level of circulating tumor cells (CTC) per milliliter of blood,
• cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).

A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.

Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique GENRE, MD; Phone Number: +33491223778; Email: drci.up@ipc.unicancer.fr

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
    • Contact: GENRE Dominique, MD; Phone Number: 033 + 33 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women aged 40-85 years old;
• BMI< 30 kg/m2;
• Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
• Affiliation to, or beneficiary of, a social security scheme.

Exclusion Criteria:

• Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
• Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
• Biliary drainage or attempt at prior biliary drainage outside the center ;
• Preliminary oncological treatment for pancreatic pathology covered by the study;
• Clinical and/or image-visible (CT/MRI) carcinosis ;
• Ascites visible on imaging (CT/MRI) ;
• Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons;
• Contraindications to an endoscopic procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Portal vein blood sample

Procedure: Blood sample in portal vein; A 6 ml blood sample will be taken from the portal vein, before and after the echo-endoscopic biopsy of the pancreatic mass. The second sample will be taken after the biopsy if there is no bile drainage, or after bile drainage if indicated. The delay between the end of the biopsy procedure and the puncture will be 5 minutes. A 6 ml peripheral blood sample will also be taken before and after the endoscopic procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure impact	Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure	5 minutes after procedure

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Fabrice CAILLOL, MD, Paoli Calmettes Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neoplastic Processes; Pancreatic Diseases; Neoplasm Metastasis; Pancreatic Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: EUS-CTC-IPC 2019-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No