Thrombosis EmbolismCAPENCT06393764
Cancer-related Venous Thromboembolic Disease - Cohort Study
An observational study of Thrombosis Embolism and Thromboses, Venous, run by University Hospital, Brest at 1 site in France.
Trial summary
Venous thromboembolic disease (VTE) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (PE)). In cancer patients, the risk of developing VTE is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombosis Embolism, Thromboses, Venous, Cancer
- What is being tested?
- Collection of biological samples
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2025to Oct 2035
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major cancer patients with venous thromboembolic disease
Who may be able to join
- Patients aged 18 years and more.
- Patients with active cancer or requiring cancer treatment at the time of their VTE episode
- Patients with documented VTE less than 2 years old
- Patients affiliated to the social security system
- Patient who has signed a written informed consent
Who cannot join
- Patient under 18
- Refusal to participate
- Incapacity to consent to the study
- Patient under guardianship
- Incapacity to communicate (comprehension disorder)
- Life expectancy of less than 6 months
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
Brest University Hospital
Brest, 29200
Francis Couturaud, Prof, +33298347348, francis.couturaud@chu-brest.fr
About this study
Official title: Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.
Venous thromboembolic disease (VTE) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (PE)). In cancer patients, the risk of developing VTE is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also increased. The study of VTE in the context of cancer is a major challenge, given the frequency of the association, the heterogeneity of the situations, the risk factors involved and the therapeutic issues in both curative and primary prevention; in this field, many uncertainties remain, justifying a study focused on the association of VTE and cancer.
Read the detailed description
Cancer is associated with a higher risk of VTE and mortality. This association is characterized by various uncertainties at pathophysiological, diagnostic, therapeutic and prognostic levels.
CAPE STUDY is a prospective, single-center interventional cohort follow-up study designed to investigate the risk of recurrence of VTE and its mechanisms in cancer patients.
The study involves the collection of biological samples from cancer patients with venous thromboembolic disease.
At inclusion and in case of recurrence of thrombosis or hemorrhage:
- Blood samples will be taken for analysis and to constitute a biobank for future assays.
- Urine samples will be collected Once a year for 5 years (and adapted to the clinical context): visit as part of routine care, or mailing of a questionnaire, or telephone contact.
- Conditions
- Thrombosis Embolism, Thromboses, Venous, Cancer
- Being tested
- Collection of biological samples
- Medical subject headings
- Embolism and Thrombosis, Venous Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesOther
Collecte of blood and urine samples
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients treated for MVTE | All the patients are included in one arm. They will undergo various type of samples. Receives: Other: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolic recurrence
Venous thromboembolic recurrence
Measured: 5 years
Secondary outcomes (3)
Major hemorrhage
Fatal haemorrhage, clinical haemorrhage associated with a fall in haemoglobin of 2g/dl or more, clear clinical haemorrhage requiring transfusion of at least 2 red blood cells packed, intracranial, medullary, retroperitoneal, pericardial, intra-articular, intra-muscular, intra-ocular, intra-pulmonary haemorrhage, any other haemorrhage considered serious by the investigator
Measured: As long as the patient is on anticoagulant treatment during the 5 years of follow-up
Mortality
Global (all causes) and secondary to recurrent VTE or hemorrhage
Measured: 5 years
Arterial events
Atrial fibrillation, cerebrovascular accident, coronary accident, arteriopathy of the lower limbs, digestive vascular accident (splanchnic, renal, mesenteric etc.).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 Oct 2025
- Primary completionOct 2035 (estimated)
- Study completionOct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françis Couturaud, Pr, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393764
- Sponsor's protocol ID
- 29BRC21.0290
- Acronym
- CAPE
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.
- ClinicalTrials.gov ID
- NCT06393764
- Acronym / sponsor ID
- CAPE / 29BRC21.0290
- Conditions
- Thrombosis Embolism, Thromboses, Venous, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Oct 2035 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 1 May 2024 (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.
Venous thromboembolic disease (VTE) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (PE)). In cancer patients, the risk of developing VTE is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also increased. The study of VTE in the context of cancer is a major challenge, given the frequency of the association, the heterogeneity of the situations, the risk factors involved and the therapeutic issues in both curative and primary prevention; in this field, many uncertainties remain, justifying a study focused on the association of VTE and cancer.
Detailed description
Cancer is associated with a higher risk of VTE and mortality. This association is characterized by various uncertainties at pathophysiological, diagnostic, therapeutic and prognostic levels.
CAPE STUDY is a prospective, single-center interventional cohort follow-up study designed to investigate the risk of recurrence of VTE and its mechanisms in cancer patients.
The study involves the collection of biological samples from cancer patients with venous thromboembolic disease.
At inclusion and in case of recurrence of thrombosis or hemorrhage:
- Blood samples will be taken for analysis and to constitute a biobank for future assays.
- Urine samples will be collected Once a year for 5 years (and adapted to the clinical context): visit as part of routine care, or mailing of a questionnaire, or telephone contact.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients treated for MVTE | – | Other: Collection of biological samplesAll the patients are included in one arm. They will undergo various type of samples. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major cancer patients with venous thromboembolic disease
Key inclusion criteria (5 listed)
- Patients aged 18 years and more.
- Patients with active cancer or requiring cancer treatment at the time of their VTE episode
- Patients with documented VTE less than 2 years old
- Patients affiliated to the social security system
- Patient who has signed a written informed consent
Key exclusion criteria (6 listed)
- Patient under 18
- Refusal to participate
- Incapacity to consent to the study
- Patient under guardianship
- Incapacity to communicate (comprehension disorder)
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 |
|---|---|---|
| Collection of biological samplesCollecte of blood and urine samples | Other | Cancer patients treated for MVTE |
Primary outcome
Venous thromboembolic recurrence
Time frame: 5 years
Venous thromboembolic recurrence
3 secondary outcomes
Major hemorrhage
Time frame: As long as the patient is on anticoagulant treatment during the 5 years of follow-up
Mortality
Time frame: 5 years
Arterial events
Time frame: 5 years
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 15 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Thrombosis Embolism
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
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.
Françis Couturaud, Pr principal investigator
CHU Brest
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 Thrombosis Embolism and Thromboses, Venous, run by University Hospital, Brest 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 5 inclusion and 6 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 15 Jun 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 Françis Couturaud, Pr (+33298347348, francis.couturaud@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolic recurrence (time frame: 5 years). 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 15 Jun 2026.