Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

NCT04677244 | Recruiting DMC

• 1 other identifier: EUS-CTC-IPC 2019-056
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

• Procedure impact

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

  5 minutes after procedure

Study Arms (1)

Portal vein blood sample

EXPERIMENTAL

Procedure: Blood sample in portal vein

Interventions

Blood sample in portal vein PROCEDURE

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.

Portal vein blood sample

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabrice CAILLOL, MD

  Paoli Calmettes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective monocentric study

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: November 11, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)