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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: |
NCT00904410 |
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Date of registration:
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15/03/2007 |
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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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Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
CHIMTEP |
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Scientific title:
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Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00904410 |
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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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Phase 4
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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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GAUTHIER Helene |
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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 Oscar Lambret |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18
- Breast cancer treated by neo-adjuvant chemotherapy (T>2cm)
- Measurable lesions ,assessed clinically and by ultrasound
- Delay minimum between biopsy and PET: 15 days
- PS-WHO: 0
Exclusion Criteria:
- T<2cm
- Inflammatory breast cancer (T4d)
- Diabetic patients unbalanced (glycemia>1.40)
- Pregnant or lactating women
Age minimum:
18 Years
Age maximum:
N/A
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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Other: FDG-PET
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Primary Outcome(s)
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Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
[Time Frame: before and 3 weeks after 1st cycle]
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Secondary Outcome(s)
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Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy
[Time Frame: 3 weeks after the 3rd cycle]
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Secondary ID(s)
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CHIMTEP 0402
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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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