Breast CancerC-PiACsNCT04645849
Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
An observational study of Breast Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Immunomonitoring
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with breast cancer and systemic treatments planed or done aged 18 to 39
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Leila GOFTI-LAROCHE, 0033 4 76 76 68 74, LGofti-laroche@chu-grenoble.fr
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Immunomonitoring
- Keywords
- Immunity recovery, post treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A or "End of treatment" | 16 patients recruited at the end of breast cancer treatment and followed during 9 months Receives: Biological: Immunomonitoring | |
| Cohort B or "Diagnosis" | Patients recruited at breast cancer before any treatment: one blood sample to provide comparative values. Receives: Biological: Immunomonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (2)
Analysis feasibility
number of samples analysed versus planned, quality of the results
Measured: 15 months
Immunity Cells and molecules kinetic analysis
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).
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start15 Jun 2020
- Primary completionAug 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila Gofti-Laroche, PharmD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645849
- Sponsor's protocol ID
- 38RC19.362
- Other IDs
- 2019-A02900-57
- Acronym
- C-PiACs
- Status last verified
- Dec 2020
- First submitted
- 15 Jun 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT04645849
- Acronym / sponsor ID
- C-PiACs / 38RC19.362
- Conditions
- Breast Cancer
- Keywords
- Immunity recovery, post treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A or "End of treatment" | – | Biological: Immunomonitoring16 patients recruited at the end of breast cancer treatment and followed during 9 months |
| Cohort B or "Diagnosis" | – | Biological: ImmunomonitoringPatients recruited at breast cancer before any treatment: one blood sample to provide comparative values. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with breast cancer and systemic treatments planed or done aged 18 to 39
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- metastatic breast cancer
- pregnant or breastfeeding woman
- Treatment with monoclonal antibodies or immunotherapy
- Immunosuppressive therapy
- Thymus irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunomonitoring16 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. | Biological | Cohort A or "End of treatment", Cohort B or "Diagnosis" |
Primary outcome
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.
2 secondary outcomes
Analysis feasibility
Time frame: 15 months
Immunity Cells and molecules kinetic analysis
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Gofti-Laroche, PharmD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leila Gofti-Laroche, PharmD (0033 4 76 76 68 74, LGofti-laroche@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the relevant biological parameters of the innate / adaptive immune system (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.