Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer

• Conditions: Breast Cancer

• Registration Number: NCT04645849
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

This study aim to determine kinetic of post treatment recovery/variation of a panel of innate and adaptative immune system cells and molecules.

The results should allow to determine the optimal post treatment immunomonitoring timing and panel to be used for future studies.

Detailed Description

There is a complexe interaction between tumor cells ans host immunity. Immunity system (IS) is clearly involved in cancer developement control, and it is suggested that it could participate to the response to anti cancer treatment.

There is however no validated immunomonitoring strategy to allow a reliable patient's immune status along time, and particularly after treatment.There are scarce existing information on immunologic reconstitution profile recovery after treatment.

This study aim to perform immunomonitoring in young patients with cancer to describe kinetic of recovery/variation of a panel of innate and adaptative immune system cells and molecules, selected by their potential relevance according to literature.

The concerned population are young women (˂40 yo) with breast cancer.

There will be 2 patients cohorts A or "End of treatment" : patients recruited at the end of treatment (study cohort) B or "Diagnosis" : Patients recruited at diagnosis (reference values)

This study should contribute to give sufficient data to determine the pertinent timing and cells/molecules panel to evaluate immunity profiling after treatment.

These results could be used for further studies.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-27
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07
• Primary Completion: 2021-08
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Women with Breast cancer at initial diagnosis OR at the end of treatment
• Chemotherapy planned or performed in the treatment plan
• Patient not opposed to participate to the present study
• Affiliated to a French social security scheme.

Exclusion Criteria

• metastatic breast cancer
• pregnant or breastfeeding woman
• Treatment with monoclonal antibodies or immunotherapy
• Immunosuppressive therapy
• Thymus irradiation
• Chronic infection in progress
• Inborn or acquired disease (other than breast cancer) impacting the immune system (SAA, Lupus...)
• Subject under guardianship or deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of the relevant biological parameters of the innate / adaptive immune system	15 months	Analysis of immune profile implies to evaluate changes of about 30 distinct immune cell (sub)types with their activation markers. These analyses are conducted at 3 time points for cohort "A or End of treatment" (1, 5, 9 months) and once for cohort "B or Diagnosis" before treatment start : -% and counts of immune cell populations (B-lymphocytes, T-lymphocytes, dendritic cells); * activation levels of cell subpopulations; * Secretion of cytokines after activation; * Determination of cytokines and chemokines after activation (picograms/ml) Description of the evolution of the parameters measured for cohort "A or End of treatment" with comparison to normal values (data from the EFS cohort and from cohort "B or Diagnosis") Analysis of the reconstitution kinetic should allow us to determine wich biological parameters (immune cell (sub)types and their activation markers) will be most relevant to study immune profile reconstitution for further studies.

Secondary Outcome Measures

Name	Time	Method
Analysis feasibility	15 months	number of samples analysed versus planned, quality of the results
Immunity Cells and molecules kinetic analysis	15 months	The objective is to determine the best moment for analysis of immune system reconstitution (cf outcome 1 measures) For each patient, and each immune system marker tested (cells/molecules): kinetic analysis of return to values comparable to reference values (data from the EFS = french blood establishment and the 8 patients tested before the start of treatment).

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble, France