Study of the Anti-tumoral Immune Response
ERISA
1 other identifier
interventional
167
1 country
1
Brief Summary
This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2014
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2014
CompletedFirst Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2021
CompletedJune 1, 2022
May 1, 2022
7.8 years
August 1, 2016
May 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Spontaneous immune responses of T cells CD4 specific tumor antigens
15 months
Secondary Outcomes (1)
T cells level
15 months
Study Arms (4)
glioma
EXPERIMENTAL1 additional blood sample for patients with glioma and without treatment
breast cancer
EXPERIMENTAL2 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+
EXPERIMENTAL1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression
Breast Cancer HER 2+ or HER2 triple -
EXPERIMENTAL1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant
Interventions
Eligibility Criteria
You may qualify if:
- Performance status 0,1 or 2
- breast cancer or glioma
- Arm glioma: patients without anti-tumoral treatment
- Arm breast cancer HER2: patients with current therapy
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Régional Universitaire
Besançon, 25030, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 3, 2016
Study Start
January 27, 2014
Primary Completion
October 27, 2021
Study Completion
October 27, 2021
Last Updated
June 1, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share