NeoplasmsTHEONCT03826043
THrombo-Embolic Event in Onco-hematology
A study testing Blood sample analysis in people with Neoplasms and Thrombosis, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population. These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Thrombosis, Coagulation Disorder
- What is being tested?
- Blood sample analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2019to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 followed for CAL cancer and admitted to the LTC in the Medicine Department.
- Age> to 18 years.
- Patient having read the information note and signed the informed consent (including specific consent for genotyping of clotting factors).
- Patient receiving social insurance.
- Weight> 50kg
- Hemoglobin level> 7.0 g / dl
Who cannot join
- Patient not benefiting as part of his treatment from hospitalization, but admitted on an ambulatory basis.
- Patient whose age is less than 18 years.
- Patient already included in the study.
- Patient considered a vulnerable person; Vulnerable people are defined in Article L1121-5 to -8:
- Pregnant women, parturients and breastfeeding mothers
- Persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8
- and persons admitted to a health or social institution for purposes other than research
- adults who are legally protected or unable to express their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Prospective Study Evaluating the Impact and Treatment of Thrombo-embolic Events in Patients With Cancer"
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.
These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.
Read more
In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system.
Read the detailed description
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.
These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.
In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.
Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system, that is to say:
- The presence of any anti-coagulant or antiplatelet treatment,
- Or abnormalities of primary or secondary hemostasis causing coagulation disorders.
Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists (AVK), anti platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study the investigator mean by hypocoagulability any situation modifying the normal coagulation system, that is to say:
- the presence of any anti-coagulant or antiplatelet treatment,
- or abnormalities of primary or secondary hemostasis causing coagulation disorders.
- Conditions
- Neoplasms, Thrombosis, Coagulation Disorder
- Being tested
- Blood sample analysis
- Keywords
- Neoplasms, Thrombosis, hypocoagulability
- Medical subject headings
- Neoplasms, Thrombosis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample analysisDiagnostic test
Thrombophilia, blood count and coagulation count
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Hospitalized patient Receives: Diagnostic Test: Blood sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of thrombosis rate in patients hospitalized for cancer
Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized
Measured: 12 months
Secondary outcomes (5)
Comparison of the values of the biological parameters of thrombophilia assessment, blood count and coagulation, at the time of the occurrence of thrombosis, between patients in a situation of hypocoagulability and patients with no hypocoagulability.
These patients in these two situations, will be identified, during the onset of thrombosis, the results of the parameters of their blood count and their intake of antiaggregant or anticoagulant treatment.
- Comparison between the hypocoagulable patient group and the non-hypocoagulable patient group of the biological parameters of the thrombophilia balance, blood counts and coagulation counts in patients with cancer at the time of the occurrence of thrombosis
- The state of hypocoagulability is defined by: thrombocytopenia <100000 / mm3, abnormality of one or more coagulation factors, platelet antiaggregant treatment, anticoagulant treatment of all kinds.
Measured: 12 months
Determination of thrombosis rate with new oral anticoagulants.
Incidence rate of first occurrence of thromboembolic events in patients with cancer, and treatment with new oral anticoagulants
Measured: 12 months
Comparison of 12-month survival of patients with or without hypocoagulability, with thrombosis.
Survival at 12 months. 12-month survival is defined as the delay between the date of inclusion and the date of death from all causes. Patients lost to follow-up will be censored on the date of the latest news. Patients will be followed for 12 months after inclusion in the study.
Measured: 12 months
• Determination of death rate due to thrombosis.
Death rate due to thrombosis is the number of deaths whose cause is thrombosis.
Measured: 12 months
Determination of the rate of hemorrhagic complications in this population.
Rate of haemorrhagic complications defined by the number of haemorrhagic events, whatever the degree of severity, of biological or medicinal origin.
- A haemorrhagic event is defined as the occurrence of bleeding by rupture of a blood vessel or effusion out of a blood vessel. Bleeding may be internal or external, see the examples provided below: Internal haemorrhage: cerebral hematoma, subdural hematoma; intramuscular hematoma
- Externalized hemorrhage: epistaxis, gingivorrhagia, externalized digestive bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start9 Sep 2019
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826043
- Sponsor's protocol ID
- 2018/23
- Other IDs
- 2018-A01120-55
- Acronym
- THEO
- Status last verified
- Sep 2025
- First submitted
- 30 Jan 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hovhannisyan A, Martin N, Guerda K, Pavliuc E, Bailleux C, Ducoulombier A, Seutin E, Ngo TH, Pace-Loscos T, Gal J, Chateau Y, Devic C, Garrido A, Peyrade F, Chamorey E, Ferrari V. Incidence and prognostic impact of venous thromboembolism in a prospective single-center cohort of patients with cancer: The THEO study. Thromb Res. 2026 Oct 11;266:109869. doi: 10.1016/j.thromres.2026.109869. Online ahead of print.
PubMed 42914739
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prospective Study Evaluating the Impact and Treatment of Thrombo-embolic Events in Patients With Cancer"
- ClinicalTrials.gov ID
- NCT03826043
- Acronym / sponsor ID
- THEO / 2018/23
- Conditions
- Neoplasms, Thrombosis, Coagulation Disorder
- Keywords
- Neoplasms, Thrombosis, hypocoagulability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 1 Feb 2019 (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 overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.
These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.
In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system.
Detailed description
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.
These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.
In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.
Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system, that is to say:
- The presence of any anti-coagulant or antiplatelet treatment,
- Or abnormalities of primary or secondary hemostasis causing coagulation disorders.
Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists (AVK), anti platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study the investigator mean by hypocoagulability any situation modifying the normal coagulation system, that is to say:
- the presence of any anti-coagulant or antiplatelet treatment,
- or abnormalities of primary or secondary hemostasis causing coagulation disorders.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Diagnostic Test: Blood sample analysisHospitalized patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient followed for CAL cancer and admitted to the LTC in the Medicine Department.
- Age> to 18 years.
- Patient having read the information note and signed the informed consent (including specific consent for genotyping of clotting factors).
- Patient receiving social insurance.
- Weight> 50kg
Key exclusion criteria (8 listed)
- Patient not benefiting as part of his treatment from hospitalization, but admitted on an ambulatory basis.
- Patient whose age is less than 18 years.
- Patient already included in the study.
- Patient considered a vulnerable person; Vulnerable people are defined in Article L1121-5 to -8:
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 |
|---|---|---|
| Blood sample analysisThrombophilia, blood count and coagulation count | Diagnostic test | Experimental arm |
Primary outcome
Evaluation of thrombosis rate in patients hospitalized for cancer
Time frame: 12 months
Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized
5 secondary outcomes
Comparison of the values of the biological parameters of thrombophilia assessment, blood count and coagulation, at the time of the occurrence of thrombosis, between patients in a situation of hypocoagulability and patients with no hypocoagulability.
Time frame: 12 months
Determination of thrombosis rate with new oral anticoagulants.
Time frame: 12 months
Comparison of 12-month survival of patients with or without hypocoagulability, with thrombosis.
Time frame: 12 months
• Determination of death rate due to thrombosis.
Time frame: 12 months
Determination of the rate of hemorrhagic complications in this population.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 42914739Hovhannisyan A, Martin N, Guerda K, Pavliuc E, Bailleux C, Ducoulombier A, Seutin E, Ngo TH, Pace-Loscos T, Gal J, Chateau Y, Devic C, Garrido A, Peyrade F, Chamorey E, Ferrari V. Incidence and prognostic impact of venous thromboembolism in a prospective single-center cohort of patients with cancer: The THEO study. Thromb Res. 2026 Oct 11;266:109869. doi: 10.1016/j.thromres.2026.109869. Online ahead of print.
- 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. This study is not recruiting at the moment.
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 Blood sample analysis in people with Neoplasms and Thrombosis, run by Centre Antoine Lacassagne 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of thrombosis rate in patients hospitalized for cancer (time frame: 12 months). 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 NCT03826043, which also lists 1 linked publication.
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 30 Sep 2025.