Cancer-related Thromboembolic Disease (PROSPECT)
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|ClinicalTrials.gov Identifier: NCT02785757|
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : March 4, 2020
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.
The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk
The secondary objectives are:
- To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
- To evaluate values of other clotting activation markers in patients with cancer
Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.
Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.
The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma||Other: Thrombin Generation Assay||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?|
|Actual Study Start Date :||July 12, 2014|
|Estimated Primary Completion Date :||February 12, 2022|
|Estimated Study Completion Date :||February 12, 2022|
Experimental: Patients with adenocarcinoma
60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
Other: Thrombin Generation Assay
- thrombin generation assay results [ Time Frame: 7 months ]
- Clotting activation markers: thrombin-antithrombin complexes (TAT) [ Time Frame: 7 months ]
- Clotting activation markers: prothrombin fragment F1+2 [ Time Frame: 7 months ]
- Clotting activation markers: D-dimer [ Time Frame: 7 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785757
|Contact: Yesim DARGAUD, MD PHD||(0)4 72 11 88 25 ext +email@example.com|
|Unité d'Hémostase Clinique Hôpital Louis Pradel||Recruiting|
|Bron, France, 69500|
|Contact: Yesim Dargaud, MD, PhD (0)4 72 11 88 25 ext +33 firstname.lastname@example.org|
|Principal Investigator: Yesim Dargaud, MD, PhD|