Study of the Anti-tumoral Immune Response (ERISA)
Primary Purpose
Breast Cancer, Glioma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Régional Universitaire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
glioma
breast cancer
breast cancer HER2+
Breast Cancer HER 2+ or HER2 triple -
Arm Description
1 additional blood sample for patients with glioma and without treatment
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.
1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression
1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant
Outcomes
Primary Outcome Measures
Spontaneous immune responses of T cells CD4 specific tumor antigens
Secondary Outcome Measures
T cells level
Full Information
NCT ID
NCT02854644
First Posted
August 1, 2016
Last Updated
May 31, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02854644
Brief Title
Study of the Anti-tumoral Immune Response
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2014 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
October 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Glioma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glioma
Arm Type
Experimental
Arm Description
1 additional blood sample for patients with glioma and without treatment
Arm Title
breast cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
breast cancer HER2+
Arm Type
Experimental
Arm Description
1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression
Arm Title
Breast Cancer HER 2+ or HER2 triple -
Arm Type
Experimental
Arm Description
1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant
Intervention Type
Other
Intervention Name(s)
additional blood sample
Primary Outcome Measure Information:
Title
Spontaneous immune responses of T cells CD4 specific tumor antigens
Time Frame
15 months
Secondary Outcome Measure Information:
Title
T cells level
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire
City
Besançon
ZIP/Postal Code
25030
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Anti-tumoral Immune Response
We'll reach out to this number within 24 hrs