NCT04645849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

June 15, 2020

Last Update Submit

December 3, 2020

Conditions

Breast Cancer

Keywords

Immunity recoverypost treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Analysis feasibility

    15 months

  • Immunity Cells and molecules kinetic analysis

    15 months

Study Arms (2)

Cohort A or "End of treatment"

16 patients recruited at the end of breast cancer treatment and followed during 9 months

Biological: Immunomonitoring

Cohort B or "Diagnosis"

Patients recruited at breast cancer before any treatment: one blood sample to provide comparative values.

Biological: Immunomonitoring

Interventions

ImmunomonitoringBIOLOGICAL

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 A or "End of treatment"Cohort B or "Diagnosis"

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples that will be destroyed after publications.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Leila Gofti-Laroche, PharmD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Gofti-Laroche, PharmD

CONTACT

0033 4 76 76 68 74LGofti-laroche@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

November 27, 2020

Study Start

June 15, 2020

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)