NCT04677244

Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Pancreas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-11
• Primary completion: 2024-11-01
• Completion: 2025-11-01
• First posted: 2020-12-21
• Last updated: 2024-04-09

Locations

1 site across 1 country: France