Solid CarcinomaTHROMBINNCT06051214
Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk
A study testing thrombogram in people with Solid Carcinoma, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Carcinoma
- What is being tested?
- thrombogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2023to Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged > 18 years,
- Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,
- Patients who have not received any systemic treatment for their cancer,
- An informed patient who does not object to the use of data for research purposes and who has consented to the collection, use and storage of biological samples.
Who cannot join
- Patient who has had a VTE in the 12 months preceding the diagnosis of cancer,
- Patient on low molecular weight heparins, standard unfractionated heparins and anti-vitamin K2,
- Women who are pregnant, likely to become pregnant or who are breast-feeding,
- Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian,
- Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.
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, 1 recruiting
- Recruiting
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805
Armelle LEFRANCOIS, armelle.lefrancois@ico.unicancer.fr
Judith RAIMBOURG, Judith.raimbourg@ico.unicancer.fr
About this study
Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis or hypocoagulability responsible for bleeding.
Due to a number of factors, cancer is associated with a state of hypercoagulability, leading to thrombosis. The incidence of venous thromboembolism (VTE) in cancer patients varies from 15 to 20% depending on the type of cancer, the stage of the disease and the associated treatments (ONCORIF data, November 2021). The risk of venous thromboembolism (VTE) is greatly increased in cancer patients (RR x 3 to 6) and doubled in the case of associated chemotherapy (1). VTE is a poor prognostic factor, occurs mainly in the first 6 months after diagnosis and is the second leading cause of death in cancer patients.
Read more
At present, haemostasis tests performed in medical laboratories independently explore the different coagulation pathways but do not allow the overall haemostatic profile of a hyper- or hypocoagulable patient to be assess.
Based on this knowledge base, the aim of our study will be to monitor thrombogram profiles during the management of patients with tumours at high risk of thromboembolism (lung, pancreas, stomach, glioblastoma) and to correlate these profiles with the risk of a thromboembolic event occurring in these patients. The aim of the project is to validate a simple predictive test (suitable for clinical use) for the risk of thromboembolism in these patients. These analyses will also make it possible to monitor the impact of chemotherapy on changes in the thrombin generation test in patients.
Read the detailed description
Biological blood samples will be taken specifically for research purposes. As far as possible and depending on the patient's schedule, a sample will be taken every month (during a consultation and/or a course of chemotherapy) and for the 12 months following the initiation of systemic treatment
- Conditions
- Solid Carcinoma
- Being tested
- thrombogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombogramBiological
blood sampling every month for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Thrombogram | Experimental | Blood sampling every month for 12 months Receives: Biological: thrombogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether changes in thrombogram values are predictive of thromboembolic events in patients with solid cancers in the 12 months following initiation of their systemic treatment.
Venous thromboembolism (VTE)-free survival.
Measured: 12 months
Secondary outcomes (3)
Describe kinetic evolution of thrombogram after different chemotherapies
Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min)
Measured: Every 3 months for 12 months
Describe kinetic evolution of thrombogram in metastatic disease
Analysis of Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min) will be done before and after metastatic progression, or at each progression for patients with immediate metastatic disease.
Measured: Every 3 months for 12 months
Identify specific patterns of thrombogram evolution over time
Homogeneous patient trajectories will be identified by evolution of Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min)
Measured: Every 3 months for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start12 Sep 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Diagnostica Stago
- Responsible party
- Sponsor
- Investigators
- Judith RAIMBOURG, MD, Principal investigator, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051214
- Sponsor's protocol ID
- ICO-2022-19
- Acronym
- THROMBIN
- Status last verified
- Feb 2026
- First submitted
- 31 Aug 2023
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk
- ClinicalTrials.gov ID
- NCT06051214
- Acronym / sponsor ID
- THROMBIN / ICO-2022-19
- Conditions
- Solid Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Diagnostica Stago
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Sep 2023 (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.
Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis or hypocoagulability responsible for bleeding.
Due to a number of factors, cancer is associated with a state of hypercoagulability, leading to thrombosis. The incidence of venous thromboembolism (VTE) in cancer patients varies from 15 to 20% depending on the type of cancer, the stage of the disease and the associated treatments (ONCORIF data, November 2021). The risk of venous thromboembolism (VTE) is greatly increased in cancer patients (RR x 3 to 6) and doubled in the case of associated chemotherapy (1). VTE is a poor prognostic factor, occurs mainly in the first 6 months after diagnosis and is the second leading cause of death in cancer patients.
At present, haemostasis tests performed in medical laboratories independently explore the different coagulation pathways but do not allow the overall haemostatic profile of a hyper- or hypocoagulable patient to be assess.
Based on this knowledge base, the aim of our study will be to monitor thrombogram profiles during the management of patients with tumours at high risk of thromboembolism (lung, pancreas, stomach, glioblastoma) and to correlate these profiles with the risk of a thromboembolic event occurring in these patients. The aim of the project is to validate a simple predictive test (suitable for clinical use) for the risk of thromboembolism in these patients. These analyses will also make it possible to monitor the impact of chemotherapy on changes in the thrombin generation test in patients.
Detailed description
Biological blood samples will be taken specifically for research purposes. As far as possible and depending on the patient's schedule, a sample will be taken every month (during a consultation and/or a course of chemotherapy) and for the 12 months following the initiation of systemic treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombogram | Experimental | Biological: thrombogramBlood sampling every month for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged > 18 years,
- Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,
- Patients who have not received any systemic treatment for their cancer,
- An informed patient who does not object to the use of data for research purposes and who has consented to the collection, use and storage of biological samples.
Key exclusion criteria (5 listed)
- Patient who has had a VTE in the 12 months preceding the diagnosis of cancer,
- Patient on low molecular weight heparins, standard unfractionated heparins and anti-vitamin K2,
- Women who are pregnant, likely to become pregnant or who are breast-feeding,
- Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian,
- Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.
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 |
|---|---|---|
| thrombogramblood sampling every month for 12 months | Biological | Thrombogram |
Primary outcome
To assess whether changes in thrombogram values are predictive of thromboembolic events in patients with solid cancers in the 12 months following initiation of their systemic treatment.
Time frame: 12 months
Venous thromboembolism (VTE)-free survival.
3 secondary outcomes
Describe kinetic evolution of thrombogram after different chemotherapies
Time frame: Every 3 months for 12 months
Describe kinetic evolution of thrombogram in metastatic disease
Time frame: Every 3 months for 12 months
Identify specific patterns of thrombogram evolution over time
Time frame: Every 3 months for 12 months
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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Judith RAIMBOURG, MD principal investigator
INSTITUT DE CANCEROLOGIE DE L'OUEST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thrombogram in people with Solid Carcinoma, run by Institut Cancerologie de l'Ouest 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 Armelle LEFRANCOIS (+33240679727, armelle.lefrançois@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether changes in thrombogram values are predictive of thromboembolic events in patients with solid cancers in the 12 months following initiation of their systemic treatment. (time frame: 12 months). 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 17 Feb 2026.