Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

Cancer of Pancreas Clinical Trial

— EUS-CTC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677244
• Other study ID #: EUS-CTC-IPC 2019-056
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: November 1, 2025

Study information

• Verified date: April 2024
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Neoplastic Cells, Circulating
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure impact	Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure	5 minutes after procedure