Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

Last updated: April 8, 2024
Sponsor: Institut Paoli-Calmettes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Treatment

Blood sample in portal vein

Clinical Study ID

NCT04677244
EUS-CTC-IPC 2019-056
  • Ages 40-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women aged 40-85 years old;
  • BMI< 30 kg/m2;
  • Patients suspected of having pancreatic cancer for whom an ultrasound endoscopicbiopsy and/or biliary drainage is planned;
  • Affiliation to, or beneficiary of, a social security scheme.

Exclusion

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 protectionmeasure, 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, socialor psychological reasons;
  • Contraindications to an endoscopic procedure.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Blood sample in portal vein
Phase:
Study Start date:
November 11, 2021
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Active - Recruiting

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