Cancer-related Venous Thromboembolic Disease - Cohort Study

NCT06393764 | Not Yet Recruiting

• 1 other identifier: 29BRC21.0290
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thrombosis Embolism; Thromboses, Venous; Cancer

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolic recurrence

  Venous thromboembolic recurrence

  5 years

Secondary Outcomes (3)

• Major hemorrhage

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

• Mortality

  5 years

• Arterial events

  5 years

Study Arms (1)

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

Collection of biological samples OTHER

Collecte of blood and urine samples

Cancer patients treated for MVTE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major cancer patients with venous thromboembolic disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Embolism and Thrombosis; Venous Thrombosis; Neoplasms

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Françis Couturaud, Pr

  CHU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Françis Couturaud, Pr

CONTACT

+33298347348; francis.couturaud@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 1, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2034
• Study Completion (Estimated): November 1, 2034
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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