Hematologic NeoplasmsNEO-COAGNCT07234630
Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy
An observational study of Hematologic Neoplasms and Solid Tumor Metastatic Cancer Advanced Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of this research is to measure fibrinolytic activity in neoplastic pathologies in order to provide preliminary data on which to base a future, larger-scale study to determine predictive markers of complication in order to improve patient management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms, Solid Tumor Metastatic Cancer Advanced Cancer, Disseminated Intravascular Coagulation
- What is being tested?
- An additional volume of blood will be drawn as part of routine follow-up care
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Feb 2028
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The populations studied are neoplasia carriers with coagulopathy defined by the association of thrombocytopenia (<100G/L) and increased INR (>1.2). Adult patients hospitalized in Emergency Medicine, Intensive Care Medicine or Hepatobiliary and Digestive Surgery Service.
Who may be able to join
- For all groups:
- Age > 18 years
- Patient hospitalized in Emergency Medicine, Intensive Care Medicine or Hematology/Oncology Intensive Care, Hematology/Oncology Service or Hepatobiliary and Digestive Surgery Service
- Coagulopathy defined by the combination of thrombocytopenia (< 100 G/L) and increased INR (>1.2)
- Group 1: Malignant hemopathies with large tumor masses:
- Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
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- Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria (3).
- Group 2: Locally advanced or metastatic solid tumors with DIC:
- Prostatic adenocarcinoma
- Malignant pancreatic or biliary tract tumor (cholangiocarcinoma),
- Scheduled complex hepatobiliary carcinological surgery,
- Metastatic adenocarcinoma of the digestive tract.
- Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy): Septic shock
Who cannot join
- Patient under protective supervision (guardianship or curatorship)
- Pregnant women
- Patients weighing less than 50 kg
- Patient already included in the study
- Congenital hemostasis disorders
- Active bleeding at the time of inclusion
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- Patient with cirrhosis
- Patients receiving curative anticoagulation therapy
- Patients with a spontaneous INR > 1.2 in a previous blood test in a context of fibrinolytic insufficiency
- Each group is exclusive of the other, for example :
- For Group 1 (Neoplastic pathologies): Presence of documented sepsis at the time of inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Raphaël Clere-Jehl, +33 3 88 12 82 23, raphael.clere@chru-strasbourg.fr
Clere-Jehl, raphael.clere@chru-strasbourg.fr
About this study
The aim of this research is to measure fibrinolytic activity in neoplastic pathologies in order to provide preliminary data on which to base a future, larger-scale study to determine predictive markers of complication in order to improve patient management.
Primary purpose: measure plasminogen concentration on day 1 in subjects diagnosed with malignant hematological disease, solid tumors, or septic shock, with coagulopathy.
Read more
Secondary purpose:
- Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with solid tumor
- Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with septic shock
- Estimate the difference in plasminogen concentration on Day 1 in patients with coagulopathy between subjects with a diagnosis of solid tumor and those with septic shock.
In the 3 groups, subjects with a diagnosis of haematological malignancy, solid tumor, septic shock, presenting with coagulopathy:
- Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a bleeding complication within 28 days of admission to critical care.
- Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a thrombotic complication, within 28 days of admission to critical care.
- Evaluate the predictive performance of circulating active plasminogen concentration on Day 1 in the need for extra renal purification within 28 days of admission to critical care.
- Estimate the differences at each time point (D1, D3, D7) in haemostasis markers and markers of fibrinolytic activity and its regulation.
Assess the link between fibrinolytic activity and :
- The diagnosis of disseminated intravascular coagulation (DIC),
- The risk of haemorrhage
- Risk of organ failures
- Thrombotic risk
- Risk of organ failure
- Neutrophile activation and circulating NETs levels
- Conditions
- Hematologic Neoplasms, Solid Tumor Metastatic Cancer Advanced Cancer, Disseminated Intravascular Coagulation
- Being tested
- An additional volume of blood will be drawn as part of routine follow-up care
- Medical subject headings
- Hematologic Neoplasms, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An additional volume of blood will be drawn as part of routine follow-up careBiological
The biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube).
Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Hematological malignancies with large tumor masses | * Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
* Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria. Receives: Biological: An additional volume of blood will be drawn as part of routine follow-up care | |
| Group 2: Locally advanced or metastatic solid tumors with DIC | * Prostatic adenocarcinoma
* Malignant pancreatic or biliary tract tumor (cholangiocarcinoma),
* Scheduled complex hepatobiliary carcinological surgery,
* Metastatic adenocarcinoma of the digestive tract. Receives: Biological: An additional volume of blood will be drawn as part of routine follow-up care | |
| Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy) | Defined according to Sepsis-criteria Receives: Biological: An additional volume of blood will be drawn as part of routine follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.
The biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care.
Measured: Day 1
Secondary outcomes (3)
Measurement of various haemostasis markers
Measurement of platelet count, PT/INR, aPTT, fibrinogen, factor V, D-dimers, antithrombin III, factor VIII
Measured: Day 1, 3 and 7
Measurement of markers of fibrinolytic activity and its regulation
Assay of t-PA, u-PA, PAI-1, u-PAR, plasmin activity
Measured: Day 1, 3 and 7
Analysis of parameters closely associated with serum NET assays
Measurement of neutrophil fluorescence, circulating nucleosomes
Measured: Day 1, 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël Clere-Jehl, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234630
- Sponsor's protocol ID
- 9558
- Acronym
- NEO-COAG
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy
- ClinicalTrials.gov ID
- NCT07234630
- Acronym / sponsor ID
- NEO-COAG / 9558
- Conditions
- Hematologic Neoplasms, Solid Tumor Metastatic Cancer Advanced Cancer, Disseminated Intravascular Coagulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Nov 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 aim of this research is to measure fibrinolytic activity in neoplastic pathologies in order to provide preliminary data on which to base a future, larger-scale study to determine predictive markers of complication in order to improve patient management.
Primary purpose: measure plasminogen concentration on day 1 in subjects diagnosed with malignant hematological disease, solid tumors, or septic shock, with coagulopathy.
Secondary purpose:
- Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with solid tumor
- Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with septic shock
- Estimate the difference in plasminogen concentration on Day 1 in patients with coagulopathy between subjects with a diagnosis of solid tumor and those with septic shock.
In the 3 groups, subjects with a diagnosis of haematological malignancy, solid tumor, septic shock, presenting with coagulopathy:
- Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a bleeding complication within 28 days of admission to critical care.
- Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a thrombotic complication, within 28 days of admission to critical care.
- Evaluate the predictive performance of circulating active plasminogen concentration on Day 1 in the need for extra renal purification within 28 days of admission to critical care.
- Estimate the differences at each time point (D1, D3, D7) in haemostasis markers and markers of fibrinolytic activity and its regulation.
Assess the link between fibrinolytic activity and :
- The diagnosis of disseminated intravascular coagulation (DIC),
- The risk of haemorrhage
- Risk of organ failures
- Thrombotic risk
- Risk of organ failure
- Neutrophile activation and circulating NETs levels
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Hematological malignancies with large tumor masses | – | Biological: An additional volume of blood will be drawn as part of routine follow-up care* Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or * Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria. |
| Group 2: Locally advanced or metastatic solid tumors with DIC | – | Biological: An additional volume of blood will be drawn as part of routine follow-up care* Prostatic adenocarcinoma * Malignant pancreatic or biliary tract tumor (cholangiocarcinoma), * Scheduled complex hepatobiliary carcinological surgery, * Metastatic adenocarcinoma of the digestive tract. |
| Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy) | – | Biological: An additional volume of blood will be drawn as part of routine follow-up careDefined according to Sepsis-criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The populations studied are neoplasia carriers with coagulopathy defined by the association of thrombocytopenia (<100G/L) and increased INR (>1.2). Adult patients hospitalized in Emergency Medicine, Intensive Care Medicine or Hepatobiliary and Digestive Surgery Service.
Key inclusion criteria (13 listed)
- Age > 18 years
- Patient hospitalized in Emergency Medicine, Intensive Care Medicine or Hematology/Oncology Intensive Care, Hematology/Oncology Service or Hepatobiliary and Digestive Surgery Service
- Coagulopathy defined by the combination of thrombocytopenia (< 100 G/L) and increased INR (>1.2)
- Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
- Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria (3).
Key exclusion criteria (11 listed)
- Patient under protective supervision (guardianship or curatorship)
- Pregnant women
- Patients weighing less than 50 kg
- Patient already included in the study
- Congenital hemostasis disorders
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 |
|---|---|---|
| An additional volume of blood will be drawn as part of routine follow-up careThe biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube). Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses. | Biological | Group 1: Hematological malignancies with large tumor masses, Group 2: Locally advanced or metastatic solid tumors with DIC, Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy) |
Primary outcome
Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.
Time frame: Day 1
The biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care.
3 secondary outcomes
Measurement of various haemostasis markers
Time frame: Day 1, 3 and 7
Measurement of markers of fibrinolytic activity and its regulation
Time frame: Day 1, 3 and 7
Analysis of parameters closely associated with serum NET assays
Time frame: Day 1, 3 and 7
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 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Raphaël Clere-Jehl principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Neoplasms and Solid Tumor Metastatic Cancer Advanced Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
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 13 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Dec 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 France. 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?
Contact Raphaël Clere-Jehl (+33 3 88 12 82 23, raphael.clere@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.