UnknownNot Applicable

Cancer-related Thromboembolic Disease

France18 participantsStarted 2014-07-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

thrombin generation assay results

Timeframe: 7 months

Trial details

NCT IDNCT02785757

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-12

Contact for this trial

Yesim DARGAUD, MD PHD

(0)4 72 11 88 25 ydargaud@univ-lyon1.fr

View on ClinicalTrials.gov More Adenocarcinoma trials