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

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ClinicalTrials.gov Identifier: NCT00285038
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : December 14, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Phase
Deep Vein Thrombosis Phase 2

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 Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: US-Doppler for the Diagnosis of Asymptomatic DVT in Gynecologic Cancer Patients
Study Start Date : March 2006
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Beck-Razi, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00285038     History of Changes
Other Study ID Numbers: NIRACTIL
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: January 2006

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