Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer (C-PiACs)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: Immunomonitoring

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 Type: Observational
• Enrollment (Anticipated): 26

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Leila GOFTI-LAROCHE; Phone Number: 0033 4 76 76 68 74; Email: LGofti-laroche@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer and systemic treatments planed or done aged 18 to 39

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A or "End of treatment"; 16 patients recruited at the end of breast cancer treatment and followed during 9 months	Biological: Immunomonitoring; 16 patients will be recruited at the end of treatment: an immunoprofiling analysis will be performed out of a blood sample about 1 month, 5 months and 9 months after treatment. 8 patients will be recruited at diagnosis: a immune profile analysis will be performed before the start of treatment. This will give comparative values for the immune system cells and molecules.
Cohort B or "Diagnosis"; Patients recruited at breast cancer before any treatment: one blood sample to provide comparative values.	Biological: Immunomonitoring; 16 patients will be recruited at the end of treatment: an immunoprofiling analysis will be performed out of a blood sample about 1 month, 5 months and 9 months after treatment. 8 patients will be recruited at diagnosis: a immune profile analysis will be performed before the start of treatment. This will give comparative values for the immune system cells and molecules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the relevant biological parameters of the innate / adaptive immune system	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.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis feasibility	number of samples analysed versus planned, quality of the results	15 months
Immunity Cells and molecules kinetic analysis	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).	15 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Leila Gofti-Laroche, PharmD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Immunity recovery; post treatment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 38RC19.362; 2019-A02900-57 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No