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Determination of Predictive Value of Echography Doppler Abnormalities (CAVECCAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00714909
First received: July 11, 2008
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition
Breast Cancer
Upper Extremity Deep Vein Thrombosis, Secondary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: November 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients treated receiving adjuvant chemotherapy for localized breast cancer in the participating centers

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714909

Contacts
Contact: Philippe M Debourdeau, MD +33 1 4249 9768 onco.debourdeau@yahoo.fr

Locations
France
Saint-Louis Hospital Recruiting
Paris, France, 75010
Contact: Philippe M Debourdeau, MD     +33 1 4249 9768     onco.debourdeau@yahoo.fr    
Principal Investigator: Philippe M Debourdeau, MD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe M Debourdeau, MD Saint-Louis Hospital, Paris, France
  More Information

No publications provided

Responsible Party: Isabelle Brindel, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00714909     History of Changes
Other Study ID Numbers: K070104
Study First Received: July 11, 2008
Last Updated: February 22, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Breast cancer
Catheter related thrombosis
Diagnosis
Echography doppler
Risk factors

Additional relevant MeSH terms:
Breast Neoplasms
Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013