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ENROLLING BY INVITATION
NCT06967662
NA

Selective Plasma Adsorption of Extracellular DNA in Prevention of Intraoperative Metastasis in Pancreatic Cancer (Pilot Study)

Sponsor: Ilyinskaya Hospital, JSC

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if selective plasma adsorption of extracellular DNA works to prevent formation of metastases of pancreatic cancer during surgical removal of the tumor. It will also help researchers to learn about the safety of selective plasma adsorption of extracellular DNA during the surgery. The main questions it aims to answer are: * Does selective plasma adsorption of extracellular DNA improve the survival of participants after surgical removal of pancreatic cancer? * Does selective plasma adsorption of extracellular DNA reduce the risk of the recurrence of pancreatic cancer? * What medical problems do participants have when they receive selective plasma adsorption of extracellular DNA during surgical removal of pancreatic cancer? Researchers will compare clinical data of participants who had selective plasma adsorption of extracellular DNA and those who did not to see if there are any differences in their health. Participants who are scheduled for surgical removal of pancreatic cancer by their doctor according to medical indications will: * Either receive selective plasma adsorption of extracellular DNA during surgical removal of pancreatic cancer and on the next day after the surgery, or not. * Do blood tests prior to surgery, during the surgery, on the next day after the surgery, one week after the surgery, 3, 6, 9, and 12 months after the surgery. * Do computed tomography scans 3, 6, 9, and 12 months after the surgery. Participants will receive selective plasma adsorption of extracellular DNA, blood tests, and computed tomography scans for free.

Official title: Pilot Study of the Effectiveness of Selective Plasma Adsorption of Extracellular DNA as a Method for Preventing Intraoperative Metastasis in Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-04-04

Completion Date

2027-04-04

Last Updated

2025-05-16

Healthy Volunteers

No

Interventions

PROCEDURE

Selective plasma adsorption of extracellular DNA

Selective plasma adsorption of extracellular DNA using NucleoCor® sorption columns (Pocard Ltd., Russia) on the Spectra Optia™ Apheresis System (Terumo Blood and Cell Technologies, USA). NucleoCor® is a sorption column for plasma adsorption containing porous spherical agarose beads with a ligand that selectively binds extracellular DNA. This medical device has a Registration Certificate No. РЗН 2022/18982 in Russian Federation. Participants will receive selective plasma adsorption of extracellular DNA twice: once during the tumor removal surgery (the procedure will be initiated at the time of pancreatic tumor mobilization and will be stopped an hour after removal of the organ complex) and once on the day after the surgery.

Locations (1)

Ilyinskaya Hospital, JSC

Moscow, Moscow Oblast, Russia