ERISA: Study of the Anti-tumoral Immune Response

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT02854644

Collaborator

(none)

167

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Glioma	Other: additional blood sample	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jan 27, 2014

Actual Primary Completion Date :

Oct 27, 2021

Actual Study Completion Date :

Oct 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: glioma 1 additional blood sample for patients with glioma and without treatment	Other: additional blood sample
Experimental: breast cancer 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.	Other: additional blood sample
Experimental: breast cancer HER2+ 1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression	Other: additional blood sample
Experimental: Breast Cancer HER 2+ or HER2 triple - 1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant	Other: additional blood sample

Outcome Measures

Primary Outcome Measures

Spontaneous immune responses of T cells CD4 specific tumor antigens [15 months]

Secondary Outcome Measures

T cells level [15 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Régional Universitaire	Besançon		France	25030

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02854644

Other Study ID Numbers:

P/2013/188

First Posted:

Aug 3, 2016

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Breast Neoplasms

Glioma

Study Results

No Results Posted as of Jun 1, 2022