- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03255486
Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN) (IDEASEIN)
Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Montpellier, France, 34298
- Institut Regional du Cancer de Montpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
proven invasive breast adenocarcinoma (cytology and / or biopsy).
- 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:
presence of metastatic disease at diagnosis.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
predictive molecular abnormalities assessment
Time Frame: up to 5 years
|
Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
|
up to 5 years
|
Collaborators and Investigators
Investigators
- Study Director: marc YCHOU, Institut Regional du Cancer de Montpellier
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICM2013/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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