Pancreatic Ductal Adenocarcinoma (PDAC)INTRACOR_pilotNCT06967662
Selective Plasma Adsorption of Extracellular DNA in Prevention of Intraoperative Metastasis in Pancreatic Cancer (Pilot Study)
A study testing Selective plasma adsorption of extracellular DNA in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Ilyinskaya Hospital, JSC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- Selective plasma adsorption of extracellular DNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteRussia
- Study dates
- 4 Apr 2025to 4 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study of the Effectiveness of Selective Plasma Adsorption of Extracellular DNA as a Method for Preventing Intraoperative Metastasis in Pancreatic Cancer
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- Selective plasma adsorption of extracellular DNA
- Keywords
- PDAC, NETs, plasma adsorbtion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective plasma adsorption of extracellular DNAProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1 year after the intervention
Recurrence-free survival
Measured: 1 year after the intervention
Secondary outcomes (1)
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).
Measured: 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start4 Apr 2025
- Primary completion4 Apr 2027 (estimated)
- Study completion4 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilyinskaya Hospital, JSC
- Sponsor type
- University, hospital or other
- Collaborators
- POCARD Ltd., University Clinic of Lomonosov Moscow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967662
- Sponsor's protocol ID
- 01/2025
- Acronym
- INTRACOR_pilot
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Publications
Zhu T, Zou X, Yang C, Li L, Wang B, Li R, Li H, Xu Z, Huang D, Wu Q. Neutrophil extracellular traps promote gastric cancer metastasis by inducing epithelial-mesenchymal transition. Int J Mol Med. 2021 Jul;48(1):127. doi: 10.3892/ijmm.2021.4960. Epub 2021 May 20.
PubMed 34013374Zhang L, Jin R, Yang X, Ying D. A population-based study of synchronous distant metastases and prognosis in patients with PDAC at initial diagnosis. Front Oncol. 2023 Jan 26;13:1087700. doi: 10.3389/fonc.2023.1087700. eCollection 2023.
PubMed 36776324Yang LY, Luo Q, Lu L, Zhu WW, Sun HT, Wei R, Lin ZF, Wang XY, Wang CQ, Lu M, Jia HL, Chen JH, Zhang JB, Qin LX. Increased neutrophil extracellular traps promote metastasis potential of hepatocellular carcinoma via provoking tumorous inflammatory response. J Hematol Oncol. 2020 Jan 6;13(1):3. doi: 10.1186/s13045-019-0836-0.
PubMed 31907001Yang D, Liu J. Neutrophil Extracellular Traps: A New Player in Cancer Metastasis and Therapeutic Target. J Exp Clin Cancer Res. 2021 Jul 16;40(1):233. doi: 10.1186/s13046-021-02013-6.
PubMed 34271947Wculek SK, Malanchi I. Neutrophils support lung colonization of metastasis-initiating breast cancer cells. Nature. 2015 Dec 17;528(7582):413-7. doi: 10.1038/nature16140. Epub 2015 Dec 9.
PubMed 26649828Wang H, Zhang H, Wang Y, Brown ZJ, Xia Y, Huang Z, Shen C, Hu Z, Beane J, Ansa-Addo EA, Huang H, Tian D, Tsung A. Regulatory T-cell and neutrophil extracellular trap interaction contributes to carcinogenesis in non-alcoholic steatohepatitis. J Hepatol. 2021 Dec;75(6):1271-1283. doi: 10.1016/j.jhep.2021.07.032. Epub 2021 Aug 4.
PubMed 34363921Ventriglia J, Petrillo A, Huerta Alvaro M, Laterza MM, Savastano B, Gambardella V, Tirino G, Pompella L, Diana A, Iovino F, Troiani T, Martinelli E, Morgillo F, Orditura M, Cervantes A, Ciardiello F, De Vita F. Neutrophil to Lymphocyte Ratio as a Predictor of Poor Prognosis in Metastatic Pancreatic Cancer Patients Treated with Nab-Paclitaxel plus Gemcitabine: A Propensity Score Analysis. Gastroenterol Res Pract. 2018 Jun 10;2018:2373868. doi: 10.1155/2018/2373868. eCollection 2018.
PubMed 29983708Varady CBS, Oliveira AC, Monteiro RQ, Gomes T. Recombinant human DNase I for the treatment of cancer-associated thrombosis: A pre-clinical study. Thromb Res. 2021 Jul;203:131-137. doi: 10.1016/j.thromres.2021.04.028. Epub 2021 May 11.
PubMed 34015562Tohme S, Yazdani HO, Al-Khafaji AB, Chidi AP, Loughran P, Mowen K, Wang Y, Simmons RL, Huang H, Tsung A. Neutrophil Extracellular Traps Promote the Development and Progression of Liver Metastases after Surgical Stress. Cancer Res. 2016 Mar 15;76(6):1367-80. doi: 10.1158/0008-5472.CAN-15-1591. Epub 2016 Jan 12.
PubMed 26759232Shi L, Yao H, Liu Z, Xu M, Tsung A, Wang Y. Endogenous PAD4 in Breast Cancer Cells Mediates Cancer Extracellular Chromatin Network Formation and Promotes Lung Metastasis. Mol Cancer Res. 2020 May;18(5):735-747. doi: 10.1158/1541-7786.MCR-19-0018. Epub 2020 Mar 19.
PubMed 32193354Seyfried TN, Huysentruyt LC. On the origin of cancer metastasis. Crit Rev Oncog. 2013;18(1-2):43-73. doi: 10.1615/critrevoncog.v18.i1-2.40.
PubMed 23237552Najmeh S, Cools-Lartigue J, Rayes RF, Gowing S, Vourtzoumis P, Bourdeau F, Giannias B, Berube J, Rousseau S, Ferri LE, Spicer JD. Neutrophil extracellular traps sequester circulating tumor cells via beta1-integrin mediated interactions. Int J Cancer. 2017 May 15;140(10):2321-2330. doi: 10.1002/ijc.30635. Epub 2017 Mar 2.
PubMed 28177522Monti M, De Rosa V, Iommelli F, Carriero MV, Terlizzi C, Camerlingo R, Belli S, Fonti R, Di Minno G, Del Vecchio S. Neutrophil Extracellular Traps as an Adhesion Substrate for Different Tumor Cells Expressing RGD-Binding Integrins. Int J Mol Sci. 2018 Aug 9;19(8):2350. doi: 10.3390/ijms19082350.
PubMed 30096958Martin OA, Anderson RL, Narayan K, MacManus MP. Does the mobilization of circulating tumour cells during cancer therapy cause metastasis? Nat Rev Clin Oncol. 2017 Jan;14(1):32-44. doi: 10.1038/nrclinonc.2016.128. Epub 2016 Aug 23.
PubMed 27550857Kessenbrock K, Plaks V, Werb Z. Matrix metalloproteinases: regulators of the tumor microenvironment. Cell. 2010 Apr 2;141(1):52-67. doi: 10.1016/j.cell.2010.03.015.
PubMed 20371345
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effectiveness of Selective Plasma Adsorption of Extracellular DNA as a Method for Preventing Intraoperative Metastasis in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06967662
- Acronym / sponsor ID
- INTRACOR_pilot / 01/2025
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- PDAC, NETs, plasma adsorbtion
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ilyinskaya Hospital, JSCUniversity, hospital or other
- Collaborators
- POCARD Ltd., University Clinic of Lomonosov Moscow University
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 4 Apr 2027 (estimated)
- Study completion
- 4 Apr 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective plasma adsorption of extracellular DNA | Experimental | Procedure: Selective plasma adsorption of extracellular DNAPatients 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. |
| Control (no selective plasma adsorption of extracellular DNA ) | No intervention | –Patients in this arm will not recieve selective plasma adsorption of extracellular DNA. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective plasma adsorption of extracellular DNASelective 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. | Procedure or surgery | Selective plasma adsorption of extracellular DNA |
Primary outcome
Overall survival
Time frame: 1 year after the intervention
Recurrence-free survival
Time frame: 1 year after the intervention
1 secondary outcome
Detectable circulating tumor DNA
Time frame: 1 year after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 34013374Zhu T, Zou X, Yang C, Li L, Wang B, Li R, Li H, Xu Z, Huang D, Wu Q. Neutrophil extracellular traps promote gastric cancer metastasis by inducing epithelial-mesenchymal transition. Int J Mol Med. 2021 Jul;48(1):127. doi: 10.3892/ijmm.2021.4960. Epub 2021 May 20.
- Background: PubMed 36776324Zhang L, Jin R, Yang X, Ying D. A population-based study of synchronous distant metastases and prognosis in patients with PDAC at initial diagnosis. Front Oncol. 2023 Jan 26;13:1087700. doi: 10.3389/fonc.2023.1087700. eCollection 2023.
- Background: PubMed 31907001Yang LY, Luo Q, Lu L, Zhu WW, Sun HT, Wei R, Lin ZF, Wang XY, Wang CQ, Lu M, Jia HL, Chen JH, Zhang JB, Qin LX. Increased neutrophil extracellular traps promote metastasis potential of hepatocellular carcinoma via provoking tumorous inflammatory response. J Hematol Oncol. 2020 Jan 6;13(1):3. doi: 10.1186/s13045-019-0836-0.
- Background: PubMed 34271947Yang D, Liu J. Neutrophil Extracellular Traps: A New Player in Cancer Metastasis and Therapeutic Target. J Exp Clin Cancer Res. 2021 Jul 16;40(1):233. doi: 10.1186/s13046-021-02013-6.
- Background: PubMed 26649828Wculek SK, Malanchi I. Neutrophils support lung colonization of metastasis-initiating breast cancer cells. Nature. 2015 Dec 17;528(7582):413-7. doi: 10.1038/nature16140. Epub 2015 Dec 9.
- Background: PubMed 34363921Wang H, Zhang H, Wang Y, Brown ZJ, Xia Y, Huang Z, Shen C, Hu Z, Beane J, Ansa-Addo EA, Huang H, Tian D, Tsung A. Regulatory T-cell and neutrophil extracellular trap interaction contributes to carcinogenesis in non-alcoholic steatohepatitis. J Hepatol. 2021 Dec;75(6):1271-1283. doi: 10.1016/j.jhep.2021.07.032. Epub 2021 Aug 4.
- Background: PubMed 29983708Ventriglia J, Petrillo A, Huerta Alvaro M, Laterza MM, Savastano B, Gambardella V, Tirino G, Pompella L, Diana A, Iovino F, Troiani T, Martinelli E, Morgillo F, Orditura M, Cervantes A, Ciardiello F, De Vita F. Neutrophil to Lymphocyte Ratio as a Predictor of Poor Prognosis in Metastatic Pancreatic Cancer Patients Treated with Nab-Paclitaxel plus Gemcitabine: A Propensity Score Analysis. Gastroenterol Res Pract. 2018 Jun 10;2018:2373868. doi: 10.1155/2018/2373868. eCollection 2018.
- Background: PubMed 34015562Varady CBS, Oliveira AC, Monteiro RQ, Gomes T. Recombinant human DNase I for the treatment of cancer-associated thrombosis: A pre-clinical study. Thromb Res. 2021 Jul;203:131-137. doi: 10.1016/j.thromres.2021.04.028. Epub 2021 May 11.
- Background: PubMed 26759232Tohme S, Yazdani HO, Al-Khafaji AB, Chidi AP, Loughran P, Mowen K, Wang Y, Simmons RL, Huang H, Tsung A. Neutrophil Extracellular Traps Promote the Development and Progression of Liver Metastases after Surgical Stress. Cancer Res. 2016 Mar 15;76(6):1367-80. doi: 10.1158/0008-5472.CAN-15-1591. Epub 2016 Jan 12.
- Background: PubMed 32193354Shi L, Yao H, Liu Z, Xu M, Tsung A, Wang Y. Endogenous PAD4 in Breast Cancer Cells Mediates Cancer Extracellular Chromatin Network Formation and Promotes Lung Metastasis. Mol Cancer Res. 2020 May;18(5):735-747. doi: 10.1158/1541-7786.MCR-19-0018. Epub 2020 Mar 19.
- Background: PubMed 23237552Seyfried TN, Huysentruyt LC. On the origin of cancer metastasis. Crit Rev Oncog. 2013;18(1-2):43-73. doi: 10.1615/critrevoncog.v18.i1-2.40.
- Background: PubMed 28177522Najmeh S, Cools-Lartigue J, Rayes RF, Gowing S, Vourtzoumis P, Bourdeau F, Giannias B, Berube J, Rousseau S, Ferri LE, Spicer JD. Neutrophil extracellular traps sequester circulating tumor cells via beta1-integrin mediated interactions. Int J Cancer. 2017 May 15;140(10):2321-2330. doi: 10.1002/ijc.30635. Epub 2017 Mar 2.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
Related trials for Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective plasma adsorption of extracellular DNA in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Ilyinskaya Hospital, JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06967662, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.