Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)
NCT ID: NCT03255486
Last Updated: 2017-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2013-07-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Blood sample
Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).
Blood sample
Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).
Interventions
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Blood sample
Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).
Eligibility Criteria
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Inclusion Criteria
* locally advanced stage (tumor size greater than 2 cm).
* neoadjuvant chemotherapy indication validated RCP
* Patient eligible for neoadjuvant chemotherapy.
* Performance Index according to WHO or less 1.
* Patient aged 18 years and older.
* Being affiliated to a social security scheme or an equivalent scheme of social protection
* Obtaining signed informed consent, and that before any specific prequalification testing.
Exclusion Criteria
* Breast Cancer inflammatory.
* rare histologic subtypes (non ductal lobular and not).
* Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years.
* Patient pregnant or nursing or of childbearing age without effective contraception.
* Breast cancer in men.
* legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L1211-9).
18 Years
FEMALE
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Marc Ychou
Role: STUDY_DIRECTOR
Institut régional du Cancer de Montpellier
Locations
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Institut régional du Cancer de Montpellier
Montpellier, , France
Countries
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Other Identifiers
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ICM2013/12
Identifier Type: -
Identifier Source: org_study_id
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