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NCT02854644 Clinical Trial

Study of the Anti-tumoral Immune Response

Breast Cancer Clinical Trial

— ERISA  

Official title:
Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02854644
Other study ID # P/2013/188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 27, 2014
Est. completion date October 27, 2021

Study information
Verified date May 2022
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date October 27, 2021
Est. primary completion date October 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Performance status 0,1 or 2 - breast cancer or glioma - Arm glioma: patients without anti-tumoral treatment - Arm breast cancer: inclusion before treatment - Arm breast cancer HER2: patients with current therapy Exclusion Criteria: - Psychiatric disease compromising the understanding of the information or the realization of the study - vulnerable People according to the law (minors, adults under protection, private persons of freedom ...) - Unaffiliated People to the Social Security - People being for the period of exclusion from another study - Life expectancy estimated unless 3 months. - For patients in Arm glioma: patients having already begun a systematic treatment. - For patients with a breast cancer: patient already under current therapy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• additional blood sample

Locations
Country Name City State
France Centre Hospitalier Régional Universitaire Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spontaneous immune responses of T cells CD4 specific tumor antigens 15 months
Secondary T cells level 15 months
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