Clinical trial NCT00714909: Determination of Predictive Value of Echography Doppler Abnormalities
Official title: CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Upper Extremity Deep Vein Thrombosis, Secondary
Keywords: Breast cancer
Catheter related thrombosis
Diagnosis
Echography doppler
Risk factors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients treated receiving adjuvant chemotherapy for localized breast cancer in the participating centers

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital
Study officials:
affiliation: Saint-Louis Hospital, Paris, France
name: Philippe M Debourdeau, MD
role: PRINCIPAL_INVESTIGATOR
References: