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

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00285038
First received: January 30, 2006
Last updated: December 13, 2010
Last verified: January 2006
History of Changes
  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 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: US-Doppler for the Diagnosis of Asymptomatic DVT in Gynecologic Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 100
Study Start Date: March 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Gynecological Ambulatory cancer patients

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

Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Nira Beck-Razi, MD Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: Dr Beck-Razi, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00285038     History of Changes
Other Study ID Numbers: NIRACTIL
Study First Received: January 30, 2006
Last Updated: December 13, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Deep vein thrombosis
Gynecological cancer

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013