An interventional study of Selective plasma adsorption of extracellular DNA in Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by Ilyinskaya Hospital, JSC. Enrolling by invitation at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Ilyinskaya Hospital, JSC · Not applicable, Interventional, and Prevention
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:
Participants who are scheduled for surgical removal of pancreatic cancer by their doctor according to medical indications will:
Rationale for the study Tumor metastasis is the leading cause of cancer-associated mortality. In pancreatic cancer, metastases develop in more than 80% of patients (in 40-50% of cases in the first year after tumor removal surgery). All the details of the metastasis formation process are still unknown to science, but the key stages have been identified and are actively studied: tumor cell dissemination, intravasation, epithelial-mesenchymal and mesenchymal-epithelial transition, extravasation of circulating tumor cells, formation of remote pro-tumor niches, as well as evasion from immune surveillance.
The tumor microenvironment plays a key role in the formation of metastases and in modulating the response to therapy in patients with cancer. It is represented by cancer-associated fibroblasts, as well as a number of infiltrating immune cells, including cancer-associated neutrophils (CAN). CAN make up a significant proportion of all cells surrounding the tumor. It has been shown that an increase in their number is associated with metastases and, in general, a worse prognosis in a number of cancer diseases. Moreover, the neutrophil-to-lymphocyte ratio has found wide clinical application as a predictor of overall and cancer progression-related mortality.
The most studied mechanism of the positive effect of CAN on metastasis and evasion of the immune response is the production of neutrophil extracellular traps (NETs). NETs are web-like structures whose main purpose is to immobilize pathogens (bacteria, fungi, etc.). They consist of chromatin, histones, a number of signaling molecules and antimicrobial peptides. However, in cancer, the ability of NETs to entangle targets, on the contrary, promotes tumor metastasis. It has been shown that NETs surrounding a tumor cell can serve as an adhesive substrate, which mediates the anchoring of metastasis in a new niche. NETs promote the transition of naïve CD4 cells to immunosuppressive regulatory T cells, allowing metastases to further evade immune surveillance. Also, for example, NETs components such as myeloperoxidase promote tumor cell extravasation and metastasis by degrading the extracellular matrix. Co-culture of cancer cells with NETs has been shown to increase the expression of E-cadherin and vimentin, which enhances their migratory capacity.
There is a wealth of data, both in animal models and in patient biomaterial, indicating that elevated NETs levels are associated not only with cancer in general, but also with the presence of metastases. A number of studies have shown that administration of DNase, which cleaves NETs, to animals stops the spread of metastases. Moreover, clinical trials are currently underway on the use of DNase in chemotherapy (NCT00536952, NCT02462265, etc.). It is worth noting that NETs are not the only DNA-containing structures that promote metastasis. There are also cancer extracellular chromatin networks (CECN); In animal models, it has been shown that the introduction of DNase, which affects NETs and CECN, significantly reduces the likelihood of metastasis, while no decrease in the level of circulating tumor cells is observed, indicating a significant modulating role of these DNA structures in the metastasis process. At the same time, it is known that long-term use of DNase leads to a decrease in the overall survival of laboratory animals, which raises the question of when metastasis prevention should be carried out, given the ambiguous safety of this approach.
The dynamics of metastasis formation throughout a patient's life are not completely clear. There is evidence that metastasis can begin almost in parallel with the development of the primary tumor, and in such cases (the frequency of which, unfortunately, cannot be estimated) it is very difficult to influence the development of metastases. At the same time, many researchers note that the most significant (and potentially controllable) moment at which metastases can form is the invasive intervention (biopsy, perhaps to a greater extent - resection). According to the results of dozens of studies in various types of oncological diseases in patients and in animal models, it is noted that invasive intervention is significantly associated with both an increase in the level of circulating tumor cells and the development of metastases (dissemination of cells along the needle or when tumor tissue is damaged; the occurrence of a proinflammatory background that promotes the breakdown of the extracellular matrix and extravasation, etc.).
Thus, there is a need to develop a technology for intraoperative prevention of metastasis formation based on the removal of DNA-containing structures (NETs and CECN) from the bloodstream of patients with pancreatic cancer, for which the use of selective plasma adsorption using the NucleoCor® sorption column might be of great value.
This is the only study on the registry with Ilyinskaya Hospital, JSC as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients in this arm will not recieve 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.
Overall survival
Time frame: 1 year after the intervention
Recurrence-free survival
Time frame: 1 year after the intervention
Detectable circulating tumor DNA
Detection of circulating tumor DNA in plasma at check-up points after the intervention (1st day, 7th day, 3rd month, 6th month, 9th month, and 12 month).
Time frame: 1 year after the intervention
Plan to share: Yes — All IPD collected throughout the trial
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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).
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
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