Study of the Anti-tumoral Immune Response

Not Applicable

Completed

• Conditions: Glioma; Breast Cancer
• Interventions: Other: additional blood sample

• Registration Number: NCT02854644
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-27
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Primary Completion: 2021-10-27
• Study Completion: 2021-10-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glioma	additional blood sample	1 additional blood sample for patients with glioma and without treatment
Breast Cancer HER 2+ or HER2 triple -	additional blood sample	1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant
breast cancer	additional blood sample	2 additional blood samples for patients with localized brest cancer, metastatic breast cancer in 1st line of treatment and breast cancer in second line of treatment.
breast cancer HER2+	additional blood sample	1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression

Primary Outcome Measures

Name	Time	Method
Spontaneous immune responses of T cells CD4 specific tumor antigens	15 months

Secondary Outcome Measures

Name	Time	Method
T cells level	15 months

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Besançon, France