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

Institut Paoli-Calmettes

Status

Enrolling

Conditions

Cancer of Pancreas

Treatments

Procedure: Blood sample in portal vein

Study type

Interventional

Funder types

Other

Identifiers

NCT04677244

EUS-CTC-IPC 2019-056

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No 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.