NCT02785757

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

9.6 years

First QC Date

May 25, 2016

Last Update Submit

January 5, 2021

Conditions

Adenocarcinoma

Keywords

adenocarcinomavenous thromboembolismthrombin generation assay

Outcome Measures

Primary Outcomes (1)

  • thrombin generation assay results

    7 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

Patients with adenocarcinoma

EXPERIMENTAL

60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy

Other: Thrombin Generation Assay

Interventions

Thrombin Generation AssayOTHER
Patients with adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Hémostase Clinique Hôpital Louis Pradel

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

AdenocarcinomaVenous Thromboembolism

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yesim DARGAUD, MD PHD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

July 12, 2014

Primary Completion

February 12, 2024

Study Completion

February 12, 2024

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

FR(1)