Breast CancerERISANCT02854644
Study of the Anti-tumoral Immune Response
A study testing additional blood sample in people with Breast Cancer and Glioma, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Glioma
- What is being tested?
- additional blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2014to 27 Oct 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status 0,1 or 2
- breast cancer or glioma
- Arm glioma: patients without anti-tumoral treatment
- Arm breast cancer: inclusion before treatment
- Arm breast cancer HER2: patients with current therapy
Who cannot join
- Psychiatric disease compromising the understanding of the information or the realization of the study
- vulnerable People according to the law (minors, adults under protection, private persons of freedom ...)
- Unaffiliated People to the Social Security
- People being for the period of exclusion from another study
- Life expectancy estimated unless 3 months.
- For patients in Arm glioma: patients having already begun a systematic treatment.
- For patients with a breast cancer: patient already under current therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma
This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.
- Conditions
- Breast Cancer, Glioma
- Being tested
- additional blood sample
- Medical subject headings
- Breast Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| glioma | Experimental | 1 additional blood sample for patients with glioma and without treatment Receives: Other: additional blood sample |
| breast cancer | Experimental | 2 additional blood samples for patients with localized brest cancer, metastatic breast cancer in 1st line of treatment and breast cancer in second line of treatment. Receives: Other: additional blood sample |
| breast cancer HER2+ | Experimental | 1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression Receives: Other: additional blood sample |
| Breast Cancer HER 2+ or HER2 triple - | Experimental | 1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant Receives: Other: additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous immune responses of T cells CD4 specific tumor antigens
Measured: 15 months
Secondary outcomes (1)
T cells level
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 posted3 Aug 2016 (estimated)
- Study start27 Jan 2014
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
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 Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854644
- Sponsor's protocol ID
- P/2013/188
- Acronym
- ERISA
- Status last verified
- May 2022
- First submitted
- 1 Aug 2016
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma
- ClinicalTrials.gov ID
- NCT02854644
- Acronym / sponsor ID
- ERISA / P/2013/188
- Conditions
- Breast Cancer, Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 27 Jan 2014 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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 evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| glioma | Experimental | Other: additional blood sample1 additional blood sample for patients with glioma and without treatment |
| breast cancer | Experimental | Other: additional blood sample2 additional blood samples for patients with localized brest cancer, metastatic breast cancer in 1st line of treatment and breast cancer in second line of treatment. |
| breast cancer HER2+ | Experimental | Other: additional blood sample1 additional blood sample for patients with metastatic breast cancer with HER2 surexpression |
| Breast Cancer HER 2+ or HER2 triple - | Experimental | Other: additional blood sample1 additional blood sample for patients with breast cancer HER2 + or HER2 triple negative treated by neo adjuvant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Performance status 0,1 or 2
- breast cancer or glioma
- Arm glioma: patients without anti-tumoral treatment
- Arm breast cancer: inclusion before treatment
- Arm breast cancer HER2: patients with current therapy
Key exclusion criteria (7 listed)
- Psychiatric disease compromising the understanding of the information or the realization of the study
- vulnerable People according to the law (minors, adults under protection, private persons of freedom ...)
- Unaffiliated People to the Social Security
- People being for the period of exclusion from another study
- Life expectancy estimated unless 3 months.
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 |
|---|---|---|
| additional blood sample | Other | Breast Cancer HER 2+ or HER2 triple -, breast cancer, breast cancer HER2+, glioma |
Primary outcome
Spontaneous immune responses of T cells CD4 specific tumor antigens
Time frame: 15 months
1 secondary outcome
T cells level
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood sample in people with Breast Cancer and Glioma, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous immune responses of T cells CD4 specific tumor antigens (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 1 Jun 2022.