Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393764
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-19
Brief Title:
Cancer-related Venous Thromboembolic Disease - Cohort Study
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Establishment of a Patient-based Cohort Cancer-related Venous Thromboembolic Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPE
Brief Summary:
Venous thromboembolic disease VTE is a common 11000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None