Study of the Anti-tumoral Immune Response (ERISA)

May 31, 2022 updated by: Centre Hospitalier Universitaire de Besancon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Centre hospitalier régional universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spontaneous immune responses of T cells CD4 specific tumor antigens
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
T cells level
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2014

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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