Clinical trial · Observational
Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
NCT04645849CI-TRIAL-00048658C-PiACsunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunomonitoring | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A or "End of treatment"
- description
- 16 patients recruited at the end of breast cancer treatment and followed during 9 months
- interventionNames
- Biological: Immunomonitoring
- label
- Cohort B or "Diagnosis"
- description
- Patients recruited at breast cancer before any treatment: one blood sample to provide comparative values.
- interventionNames
- Biological: Immunomonitoring
Primary outcomes (1)
- measure
- Identification of the relevant biological parameters of the innate / adaptive immune system
- timeFrame
- 15 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.