Development of a Model to Predict the Risk of Venous Thromboembolic Events in Patients With Metastatic Bronchopulmonary Cancer

• Conditions: Metastatic Bronchopulmonary Cancer

• Registration Number: NCT04196790
• Lead Sponsor: University Hospital, Brest

Brief Summary

Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.

In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE.

The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.

Detailed Description

Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.

In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE, particularly in adenocarcinoma.

The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2019-12-18
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20
• Primary Completion: 2021-12-18
• Study Completion: 2021-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• metastatic broncho-pulmonary cancer
• age ≥18 years
• who are eligible for chemotherapy
• non opposition obtained

Exclusion Criteria

• age <18 years
• pregnancy, breast feeding
• VTE in the past 6 months or at the time of cancer diagnosis
• surgery in the past 3 months
• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
venous thromboembolism at 12 months	12 months	objectively diagnosed VTE based on validated diagnostic tests

Secondary Outcome Measures

Name	Time	Method
overall survival	one year	overall survival
survival without progression	one year	survival without progression
VTE at 6 months	6 months	VTE at 6 months

Trial Locations

Locations (3)

CHRU de Brest; 🇫🇷 Brest, France

CH des Pays de Morlaix; 🇫🇷 Morlaix, France

CHIC de QUIMPER; 🇫🇷 Quimper, France