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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Recruiting

CT.gov ID

NCT04677244

Collaborator

(none)

Enrollment

Location

Arm

47.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Pancreas	Procedure: Blood sample in portal vein	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective monocentric studyprospective monocentric study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 11, 2021

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Procedure impact [5 minutes after procedure]
Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli Calmettes	Marseille		France	13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator: Fabrice CAILLOL, MD, Paoli Calmettes Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT04677244

Other Study ID Numbers:

EUS-CTC-IPC 2019-056

First Posted:

Dec 21, 2020

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplastic Cells, Circulating

Pancreatic Neoplasms

Study Results

No Results Posted as of Jan 20, 2022