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CompletedNCT03255486IDEASEINUpdated Aug 21, 2017

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

An interventional study of Blood sample in Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-21.

Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Read the detailed description

Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer

02

Conditions studied

  • Breast Cancer

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
164 participants (actual)

Study arms

  • 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).

    Biological: Blood sample

Interventions

  • BiologicalBlood 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).

05

What researchers measure

Primary outcomes

  1. predictive molecular abnormalities assessment

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

    Time frame: up to 5 years

06

Study locations

1 site
  • Institut régional du Cancer de Montpellier
    Montpellier, 34298, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03255486
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Jul 2013
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Aug 21, 2017

Study contacts

Marc Ychou
study director · Institut régional du Cancer de Montpellier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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