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

NCT06967662 | Enrolling By Invitation

• 1 other identifier: 01/2025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

PDAC; NETs; plasma adsorbtion

Outcome Measures

Primary Outcomes (2)

• Overall survival

  1 year after the intervention

• Recurrence-free survival

  1 year after the intervention

Secondary Outcomes (1)

• Detectable circulating tumor DNA

  1 year after the intervention

Study Arms (2)

Selective plasma adsorption of extracellular DNA

EXPERIMENTAL

Patients in this arm will recieve selective plasma adsorption of extracellular DNA during surgical removal of the tumor and on the next day after the srugery.

Procedure: Selective plasma adsorption of extracellular DNA

Control (no selective plasma adsorption of extracellular DNA )

NO INTERVENTION

Patients in this arm will not recieve selective plasma adsorption of extracellular DNA.

Interventions

Selective plasma adsorption of extracellular DNA PROCEDURE

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.

Selective plasma adsorption of extracellular DNA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Histologically and/or radiologically proven diagnosis of "Non-metastatic pancreatic ductal adenocarcinoma" of any localization, with ECOG physical status 0-1, who are scheduled for surgery for radical removal of the tumor, without previous chemotherapy (stage cT0-4 N0-2 M0) or after neoadjuvant chemotherapy (stage ycT0-4 N0-2 M0).

You may not qualify if:

• Presence of other known oncological diseases.
• General contraindication to plasma adsorption (hypoproteinemia; acute cardiovascular failure; intolerance to foreign protein; decreased (less than 90/60 mm Hg) arterial pressure; gastrointestinal bleeding; acute cerebrovascular accidents; acute anemia; severe hypoxia).

Sponsors & Collaborators

• Ilyinskaya Hospital, JSC: lead
• POCARD Ltd.: collaborator
• University Clinic of Lomonosov Moscow University: collaborator

Study Sites (1)

Ilyinskaya Hospital, JSC

Moscow, Moscow Oblast, 143421, Russia

Location

Related Publications (20)

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  BACKGROUND

• Jain M, Atayan D, Rakhmatullin T, Dakhtler T, Popov P, Kim P, Viborniy M, Gontareva I, Samokhodskaya L, Egorov V. Cell-Free Tumor DNA Detection-Based Liquid Biopsy of Plasma and Bile in Patients with Various Pancreatic Neoplasms. Biomedicines. 2024 Jan 18;12(1):220. doi: 10.3390/biomedicines12010220.

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): April 4, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: IPD will be shared upon a reasonable request containing the analysis plan. Request must be submitted to the principal investigator Dr. Egorov by email (v.egorov@ihospital.ru).

Locations

RU (1)