Ultrasound (US)-Doppler for the Diagnosis of Asymptomatic Deep Vein Thrombosis (DVT) in Gynecologic Cancer Patients

December 13, 2010 updated by: Rambam Health Care Campus

US-Doppler for the Diagnosis of Asymptomatic DVT in Gynecologic Cancer Patients

The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by Doppler ultrasound in a selected group of patients suffering from gynecological malignancies.

Study Overview

Status

Completed

Conditions

Detailed Description

The association between malignancy and venous thromboembolism (VTE) is well known. It has been shown that there is a high prevalence of VTE in gynecological malignancies. Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

NO clear guidelines are available for anticoagulant prophylaxis in a selected group of ambulatory gynecological cancer patients. It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Gynecological Ambulatory cancer patients

Description

Inclusion Criteria:

  • Gynecological cancer patients
  • Ambulatory performance status of 0-2
  • Prior to, or during, chemotherapy and/or radiation

Exclusion Criteria:

  • Before or near surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Nira Beck-Razi, MD, Ministry of Health, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

December 14, 2010

Last Update Submitted That Met QC Criteria

December 13, 2010

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRACTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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