Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
NCT ID: NCT04645849
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
26 participants
OBSERVATIONAL
2020-06-15
2021-11-30
Brief Summary
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The results should allow to determine the optimal post treatment immunomonitoring timing and panel to be used for future studies.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Cohort A or "End of treatment"
16 patients recruited at the end of breast cancer treatment and followed during 9 months
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
39 Years
FEMALE
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Leila Gofti-Laroche, PharmD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Chu Grenoble Alpes
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Leila GOFTI-LAROCHE
Role: primary
Other Identifiers
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2019-A02900-57
Identifier Type: OTHER
Identifier Source: secondary_id
38RC19.362
Identifier Type: -
Identifier Source: org_study_id