NCT02341937

Brief Summary

Patients with cancer have a high risk of deep vein thrombosis which often develops in the veins of the lower limbs. The initial evaluation of clinically suspected deep vein thrombosis includes the estimation of the clinical probability by calculating risk scores such as the Wells score and the measurement of the D-dimer. However, the usefulness and accuracy of the clinical scores and d-dimer test are lower in patients with cancer who often undergo unnecessary (serial) ultrasonography. The aim of the current study is to analyze variables that predict the presence of thrombosis and may improve the accuracy of the Wells score. In addition, various cut-off of the d-dimer will be evaluated with the goal of improving the sensibility and specificity of the test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

6 years

First QC Date

January 14, 2015

Last Update Submit

July 14, 2021

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of false negative results of the combination of the modified Wells score and D-dimer results

    3 months

Secondary Outcomes (1)

  • Sensibility, specificity, positive and negative predictive values of the modified Wells score and D-dimer

    3 months

Interventions

Diagnostic tests for suspected deep vein thrombosisOTHER

Pre-test clinical probability (Wells score), D-dimer, compression ultrasonography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with cancer and clinically suspected DVT of the lower limbs

You may qualify if:

  • All patients with cancer and clinically suspected DVT of the lower limbs

You may not qualify if:

  • Ongoing oral or parenteral anticoagulant therapy
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Marcello Di Nisio, MD

    University G. D'Annunzio, Chieti, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

IT(1)