PROSPECT: Cancer-related Thromboembolic Disease

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT02785757

Collaborator

(none)

Enrollment

Location

Arm

115.1

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?

Actual Study Start Date :

Jul 12, 2014

Anticipated Primary Completion Date :

Feb 12, 2024

Anticipated Study Completion Date :

Feb 12, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

thrombin generation assay results [7 months]

Secondary Outcome Measures

Clotting activation markers: thrombin-antithrombin complexes (TAT) [7 months]
Clotting activation markers: prothrombin fragment F1+2 [7 months]
Clotting activation markers: D-dimer [7 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
Subjects having signed Informed Consent prior to initiation of any study procedure
Covered by a Health System

Exclusion Criteria:

Known bleeding or thrombophilia disorders
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
Patient immobilized
Confirmed venous thromboembolism in the last 12 months
Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
Severe hepatic insufficiency
Life expectancy of less than 3 months
Pregnancy