Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)

NCT03255486 | Completed

• 1 other identifier: ICM2013/12
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• predictive molecular abnormalities assessment

  Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

  up to 5 years

Study Arms (1)

Blood sample

EXPERIMENTAL

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).

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marc Ychou

  Institut régional du Cancer de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 21, 2017
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 21, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)