Clinical trial NCT04645849: Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
Official title: Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Immunity recovery
post treatment
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer and systemic treatments planed or done aged 18 to 39

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of the relevant biological parameters of the innate / adaptive immune system
timeFrame: 15 months
Secondary outcomes:
measure: Analysis feasibility
timeFrame: 15 months
measure: Immunity Cells and molecules kinetic analysis
timeFrame: 15 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Leila Gofti-Laroche, PharmD
role: PRINCIPAL_INVESTIGATOR
References: