Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN) (IDEASEIN)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
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).
Sites / Locations
- Institut régional du Cancer de Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood sample
Arm Description
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).
Outcomes
Primary Outcome Measures
predictive molecular abnormalities assessment
Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT03255486
First Posted
August 10, 2017
Last Updated
August 16, 2017
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT03255486
Brief Title
Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)
Acronym
IDEASEIN
Official Title
Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
Detailed Description
Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood sample
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
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).
Primary Outcome Measure Information:
Title
predictive molecular abnormalities assessment
Description
Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
Time Frame
up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ychou
Organizational Affiliation
Institut régional du Cancer de Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Institut régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)
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