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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 30, 2006

Last Updated Date

May 16, 2007

Start Date ^†

March 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00285038 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

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 Phase

Phase II

Study Type ^†

Observational

Study Design ^†

Screening, Longitudinal, Defined Population, Prospective Study

Condition ^†

Deep Vein Thrombosis

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

100

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Amnon Amit, MD

972048542663

a_amit@rambam.health.gov .il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00285038

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Rambam Health Care Campus

Collaborators ^††

Investigators ^†

Principal Investigator:

Nira Beck-Razi, MD

Ministry of Health, Israel

Information Provided By

Rambam Health Care Campus

Verification Date

January 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.