Echo-endoscopy Biopsy Impact On The Circulating Tumor Cell Level

Study Overview

Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

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.

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.

Cancer of Pancreas

PROCEDURE: Blood sample in portal vein

EUS-CTC-IPC 2019-056

Study Record Dates

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
First Submitted 2020-12-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-08
First Submitted that Met QC Criteria 2020-12-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-09
First Posted (ACTUAL) 2020-12-21	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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 betwe

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 betwe

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dominique GENRE, MD

Phone Number: +33491223778

Email: drci.up@ipc.unicancer.fr

Participation Criteria

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:
40 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Fabrice CAILLOL, MD, Paoli Calmettes Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record