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

This study is currently recruiting participants.

Verified by Rambam Health Care Campus, January 2006

Sponsored by:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00285038

Purpose

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.

Condition	Phase
Deep Vein Thrombosis	Phase II

MedlinePlus related topics: Cancer Deep Vein Thrombosis Ultrasound

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	US-Doppler for the Diagnosis of Asymptomatic DVT in Gynecologic Cancer Patients

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment:	100
Study Start Date:	March 2006
Estimated Study Completion Date:	April 2007

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285038

Contacts

Contact: Amnon Amit, MD

972048542663

a_amit@rambam.health.gov .il

Locations

Israel
Rambam Medical Center	Recruiting
Haifa, Israel
Principal Investigator: Nira Beck-Razi, MD
Sub-Investigator: Diana Gaitini, MD
Sub-Investigator: Sarig Galit, PhD
Sub-Investigator: Benjamin Brenner, Prof
Sub-Investigator: Zvi Bernshtein, MD
Sub-Investigator: Abraham Kuten, Prof

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

Nira Beck-Razi, MD

Ministry of Health, Israel

More Information

Study ID Numbers:	NIRACTIL
Study First Received:	January 30, 2006
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00285038
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Deep vein thrombosis
Gynecological cancer

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009