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

Primary Purpose

Cancer of Pancreas

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sample in portal vein

About this trial

This is an interventional supportive care trial for Cancer of Pancreas

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Portal vein blood sample

Arm Description

Outcomes

Primary Outcome Measures

Procedure impact

Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure

Secondary Outcome Measures

Full Information

NCT ID

NCT04677244

First Posted

December 15, 2020

Last Updated

January 5, 2022

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT04677244

Brief Title

Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

Acronym

EUS-CTC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2021 (Actual)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Pancreas

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective monocentric study

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Portal vein blood sample

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Blood sample in portal vein

Intervention Description

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.

Primary Outcome Measure Information:

Title

Procedure impact

Description

Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure

Time Frame

5 minutes after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique GENRE, MD

Phone

+33491223778

drci.up@ipc.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabrice CAILLOL, MD

Organizational Affiliation

Paoli Calmettes Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

GENRE Dominique, MD

Phone

+ 33 4 91 22 37 78

Ext

033

drci.up@ipc.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

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