Determination of Predictive Value of Echography Doppler Abnormalities

Breast Cancer Clinical Trial

— CAVECCAS  

Official title:

CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00714909
• Other study ID #: K070104
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2008
• Last updated: February 22, 2011
• Start date: November 2008
• Est. completion date: May 2012

Study information

• Verified date: February 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe M Debourdeau, MD
• Phone: +33 1 4249 9768
• Email: onco.debourdeau[@]yahoo.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• women over 18

• histologically proven breast cancer

• localized breast cancer without metastasis

• adjuvant or neo adjuvant chemotherapy

• insertion of central catheter with port for chemotherapy

• central catheter for more than three months

• inform consent

• follow up for three months

Exclusion Criteria:

• ongoing anticoagulant therapy

• previous central catheter

• femoral catheter

• double lumen catheter

• central catheter without port

• platelets < 80G/L, TQ < 50%, fibrinogen < 1 g/L

• creatinin > 175mole/L

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Upper Extremity Deep Vein Thrombosis, Secondary
• Venous Thrombosis

Locations

Country	Name	City	State
France	Saint-Louis Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan		within 6 months	No