Cancer-related Venous Thromboembolic Disease - Cohort Study | NCT06393764

Studies
Cancer-related Venous Thromboembolic Disease - Cohort Study

NCT06393764

Sponsor

University Hospital, Brest

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Thrombosis Embolism
Thromboses, Venous
Cancer

Interventions

Collection of biological samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2025Actual

Primary Completion Date

Oct 2035Estimated

Completion Date

Oct 2035Estimated

First Submitted Date

Apr 19, 2024

First Submission Date that Met QC Criteria

Apr 26, 2024

First Posted Date

May 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer patients treated for MVTE		All the patients are included in one arm. They will undergo various type of samples.	Other: Collection of biological samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collection of biological samples	Other	Collecte of blood and urine samples	Cancer patients treated for MVTE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Venous thromboembolic recurrence	Venous thromboembolic recurrence	5 years

Secondary Outcomes

Measure	Description	Time Frame
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	As long as the patient is on anticoagulant treatment during the 5 years of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Major cancer patients with venous thromboembolic disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Françis Couturaud, Pr	Contact	+33298347348		francis.couturaud@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Françis Couturaud, Pr	CHU Brest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brest University Hospital	Recruiting	Brest		29200	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016769	Embolism and Thrombosis
D020246	Venous Thrombosis
D009369	Neoplasms

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Blood collected at inclusion (66.4 ml) and in case of recurrence of thrombo-embolic venous disease ( 54.5 mL) to store plasma, serum, DNA and RNA.t Tumor tissue collection (taken during excision or biopsy as part of routine care) Urine (20 to 40 mL)