Development of a Model to Predict the Risk of Venous Thro... | NCT04196790

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

NCT04196790

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Dec 20, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Metastatic Bronchopulmonary Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2019Actual

Primary Completion Date

Dec 18, 2021Estimated

Completion Date

Dec 18, 2021Estimated

First Submitted Date

Dec 8, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2019

Last Update Posted Date

Dec 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
venous thromboembolism at 12 months	objectively diagnosed VTE based on validated diagnostic tests	12 months

Secondary Outcomes

Measure	Description	Time Frame
overall survival	overall survival	one year
survival without progression	survival without progression	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

500 metastatic cancer patients prospectively recruited in this prospective cohort.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francis COUTURAUD	Contact	02-98-34-78-26		francis.couturuad@chu-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning two year and ending five years following the publication

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

URL

Not provided