Determination of Predictive Value of Echography Doppler Abnormalities (CAVECCAS)
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|ClinicalTrials.gov Identifier: NCT00714909|
Recruitment Status : Unknown
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : July 14, 2008
Last Update Posted : February 23, 2011
|Condition or disease|
|Breast Cancer Upper Extremity Deep Vein Thrombosis, Secondary|
Phlebography is the gold standard for the diagnosis of asymptomatic catheter related thrombosis but can not be performed in about 15% of patients because of arm swelling and lack of superficial veins.
Echography doppler is an easy, cheap and atraumatic way to make the diagnosis of deep vein thrombosis. The value of echography doppler has been proven for the diagnosis of symptomatic deep venous thrombosis of lower and upper limbs and for the diagnosis of proximal asymptomatic lower limbs.
To validate the echography doppler we intend to correlate asymptomatic findings to the occurrence symptomatic related catheter related thrombosis.
Patients with localized breast cancer treated with chemotherapy will be enrolled in the study. An echography doppler will be performed on day 8, 30 and 90 after catheter insertion. Findings in asymptomatic patients (thrombus visualisation, lack of vein compressibility, variation of physiologic vein blood flow) will thereafter be correlated with the presence or absence of clinical signs of catheter related thrombosis.
In order to assess if they are risk factors for catheter related thrombosis, we will determine the level D-Dimer, microparticles and the results of generation thrombin tests before and 2 days after catheter insertion.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||May 2012|
- Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan [ Time Frame: within 6 months ]
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): NCT00714909
|Contact: Philippe M Debourdeau, MD||+33 1 4249 firstname.lastname@example.org|
|Paris, France, 75010|
|Contact: Philippe M Debourdeau, MD +33 1 4249 9768 email@example.com|
|Principal Investigator: Philippe M Debourdeau, MD|
|Principal Investigator:||Philippe M Debourdeau, MD||Saint-Louis Hospital, Paris, France|