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

• ClinicalTrials.gov Identifier: NCT04645849
• Recruitment Status: Recruiting
• First Posted: November 27, 2020
• Last Update Posted: December 7, 2020
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Study Description

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.

Condition or disease	Intervention/treatment
Breast Cancer	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 Design

• Study Type: Observational
• Estimated Enrollment: 26 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
• Actual Study Start Date: June 15, 2020
• Estimated Primary Completion Date: August 2021
• Estimated Study Completion Date: November 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Identification of the relevant biological parameters of the innate / adaptive immune system [ Time Frame: 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 :

1. Analysis feasibility [ Time Frame: 15 months ]
   number of samples analysed versus planned, quality of the results
2. Immunity Cells and molecules kinetic analysis [ Time Frame: 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).

Biospecimen Retention:   Samples Without DNA

blood samples that will be destroyed after publications.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 39 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Contacts

Contact: Leila Gofti-Laroche, PharmD; 0033 4 76 76 68 74; LGofti-laroche@chu-grenoble.fr

Locations

France

Chu Grenoble Alpes; Recruiting

Grenoble, France, 38043

Contact: Leila GOFTI-LAROCHE 0033 4 76 76 68 74 LGofti-laroche@chu-grenoble.fr

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

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

More Information

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04645849
• Other Study ID Numbers: 38RC19.362; 2019-A02900-57 ( Other Identifier: ID RCB )
• First Posted: November 27, 2020
• Last Update Posted: December 7, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:

Immunity recovery; post treatment

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases