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Completed

NCT Number: NCT02854644

Study of the Anti-tumoral Immune Response

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

additional blood sample

Other

Primary outcomes

  1. Spontaneous immune responses of T cells CD4 specific tumor antigens

    Time frame: 15 months

Secondary outcomes

  1. T cells level

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: ERISA

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2016
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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