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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00245869 |
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Date of registration:
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26/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
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Scientific title:
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Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00245869 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Catherine LABBE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CRLCC René Gauducheau 44805 ST HERBLAIN |
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Name:
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François Tranquart, PR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre d'Innovation Technologique - CHRU Tours |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Breast tumor (size equal to or greater than 3 cm.). Patients with diagnosis of benign
breast tumor based on biopsy will be excluded from the study after the first
ultrasound examination.
- Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by
histology.
- Performance status = 0, 1 or 2
- No previous surgery or local radiotherapy
Exclusion Criteria:
- Psychiatric disorders
- Vital threat due to other disease
- Vital prognosis < 3 months
- Biopsy of the lesion performed within 1 month before the ultrasonography
- Patient known to have a coronary syndrome
- Unstable angina and myocardial infarction
- Acute cardiac failure, Class III/IV cardiac failure
- Several arrhythmias
- Acute endocarditis
- Prosthetic valves
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Procedure: Contrast-enhanced Ultrasound
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Primary Outcome(s)
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From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
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Secondary ID(s)
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CT03-FD/COR
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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