Ovarian CarcinomaGYNECO-IMM&CONCT04562623
Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma
An observational study of Ovarian Carcinoma and Breast Carcinoma, run by Centre Leon Berard at 1 site in France.
Trial summary
GYNECO-IMM\&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Breast Carcinoma
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients with operable ovarian or breast cancer : patients with high grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III > 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C).
Who may be able to join
- I1. Female patients aged ≥ 18 tears at time of inform consent signature.
- I2. Patient with planned primitive tumor surgery listed below : High grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III > 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C).
- Note : Patients previously treated by neoadjuvant chemotherapy are eligible and all chemotherapies are authorized.
- I3. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures and should be willing to comply procedures required per protocol.
- I4. Patient must be covered by a medical insurance.
Who cannot join
- E1. Patient under guardianship or trusteeship.
- E2. Cancer with constitutional BRCA1/2 mutation.
- E3. Previously treated by immunomodulators (PD1/PDL1, CTLA4).
- E4. Systemic treatment by an immunosuppressor (including, but not limited to, corticosteroids, azathioprine, methotrexate, thalidomide and anti-TNF-alpha) or by an immunostimulant within 2 weeks before inclusion, except corticosteroids listed below: inhaled corticosteroids, intranasal corticosteroids, topic corticosteroids, and systemic corticosteroids with prednisone or equivalent physiological dose ≤ 10 mg/day.
- E5. Patient with known history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis,systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipids syndrome, Wegener syndrome , Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vascularitis, or glomerulonephritis, B or C hepatitis infection, HIV infection.
- E6. Patient with other active tumor except if the tumor is considered not to interfere with outcome measures following sponsor approval such as basal or squamous cell skin cancer. Patient previously treated for an other cancer and without relapse for at least one year are eligible.
- E7. Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, France, 69008
Nicolas Chopin, nicolas.chopin@lyon.unicancer.fr
About this study
GYNECO-IMM\&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma.
Read the detailed description
Breast cancer is the main cancer in women and is the second cause of mortality by cancer in the world for women ; high grade serous ovarian cancer is a rare pathology but survival is less 25% at 5 years.
Breast and ovarian cancers are complex entities with heterogeneous tumor cells but also normal cells including immune cells with represent the microenvironment of the tumor.This microenvironment limits tumor progression but also has been shown to play a crucial role in disease progression, tumor angiogenesis, maintenance and resistance to anticancer therapies.
Despite newly developed immunotherapies, only one-third of patients with breast and ovarian cancer responds to checkpoint inhibitors ; so today there is poor benefit to treat breast and ovarian cancers with immunotherapies. Therefore it needs to better understand immune mechanisms which reduce treatment efficacy. The aim of this clinical study is to better understand mechanisms of immune response inhibition in breast and ovarian cancers. It would characterize actionable targets in patients with resistance to conventional anticancer treatments or immunotherapies.In this context, the hypothesis is that some specific phenotypical or functional alterations of specific immune cells populations (DC, LB, plasmocytes IgA, neutrophils, NK cells, CD8+CD39+ LT, Treg) induce tumoral progression in breast and ovarian cancer. These immune populations will be described (qualitative, quantitative and functional descriptions ; proteic, transcriptomic and genomic profiles) in order to i) determine new immune surveillance mechanisms ii) new targets which allow efficient antitumoral immunity in breast and ovarian cancers.
- Conditions
- Ovarian Carcinoma, Breast Carcinoma
- Keywords
- Ovarian cancer, Breast cancer, Immune alterations, Predictive biomarkers
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A : High grade serous ovarian carcinoma | Not described | |
| Cohort B :Breast carcinoma SBR grade II or III | Breast carcinoma SBR grade II or III superior to 3 cm | |
| Cohort C : Extended Breast carcinoma In situ | Extended Breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of immune cells populations on tumour sample from exeresis
Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry, electrochemiluminescence and proliferation test
Measured: At surgery
Secondary outcomes (7)
Characterization of immune cells populations on blood sample
Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry and electrochemiluminescence
Measured: At surgery
Characterization of transcriptomic profile of immune cells populations
Biomarkers expression, activation or inhibition of functional pathways will be determined by transcriptome sequencing (RNAseq and single cell RNAseq) on tumor sample
Measured: At surgery
Characterization of molecular profile of tumor sample
Genes profile (Mutation, amplification, insertion, deletion) will be determined by whole exome sequencing (WES)
Measured: At surgery
Comparison of soluble factors of the tumor microenvironment with soluble factors present in the blood
Comparative characterization (nature and concentration) by Luminex technology MSD
Measured: At surgery
Characterization of immunoglobulins and their antigenic targets
Characterization by Elisa and Luminex
Measured: At surgery
Characterization of TCR repertory of LT CD8+ and Tregs
TCR repertory of LT CD8+ and Tregs will be determined by transcriptomic profile by RNAseq
Measured: At surgery
Determination of the correlation between biological characterizations at surgery and clinical characterizations
Clinical characterizations are consistent with treatment response and survival ; biological characteristics will describe molecular and transcriptomic profile of the tumor.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Jul 2021
- Primary completionJul 2026 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Center of Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562623
- Sponsor's protocol ID
- ET19-283
- Acronym
- GYNECO-IMM&CO
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT04562623
- Acronym / sponsor ID
- GYNECO-IMM&CO / ET19-283
- Conditions
- Ovarian Carcinoma, Breast Carcinoma
- Keywords
- Ovarian cancer, Breast cancer, Immune alterations, Predictive biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Cancer Research Center of Lyon
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 24 Sep 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.
GYNECO-IMM\&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma.
Detailed description
Breast cancer is the main cancer in women and is the second cause of mortality by cancer in the world for women ; high grade serous ovarian cancer is a rare pathology but survival is less 25% at 5 years.
Breast and ovarian cancers are complex entities with heterogeneous tumor cells but also normal cells including immune cells with represent the microenvironment of the tumor.This microenvironment limits tumor progression but also has been shown to play a crucial role in disease progression, tumor angiogenesis, maintenance and resistance to anticancer therapies.
Despite newly developed immunotherapies, only one-third of patients with breast and ovarian cancer responds to checkpoint inhibitors ; so today there is poor benefit to treat breast and ovarian cancers with immunotherapies. Therefore it needs to better understand immune mechanisms which reduce treatment efficacy. The aim of this clinical study is to better understand mechanisms of immune response inhibition in breast and ovarian cancers. It would characterize actionable targets in patients with resistance to conventional anticancer treatments or immunotherapies.In this context, the hypothesis is that some specific phenotypical or functional alterations of specific immune cells populations (DC, LB, plasmocytes IgA, neutrophils, NK cells, CD8+CD39+ LT, Treg) induce tumoral progression in breast and ovarian cancer. These immune populations will be described (qualitative, quantitative and functional descriptions ; proteic, transcriptomic and genomic profiles) in order to i) determine new immune surveillance mechanisms ii) new targets which allow efficient antitumoral immunity in breast and ovarian cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A : High grade serous ovarian carcinoma | – | – |
| Cohort B :Breast carcinoma SBR grade II or III | – | –Breast carcinoma SBR grade II or III superior to 3 cm |
| Cohort C : Extended Breast carcinoma In situ | – | –Extended Breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with operable ovarian or breast cancer : patients with high grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III > 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C).
Key inclusion criteria (5 listed)
- I1. Female patients aged ≥ 18 tears at time of inform consent signature.
- I2. Patient with planned primitive tumor surgery listed below : High grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III > 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C).
- Note : Patients previously treated by neoadjuvant chemotherapy are eligible and all chemotherapies are authorized.
- I3. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures and should be willing to comply procedures required per protocol.
- I4. Patient must be covered by a medical insurance.
Key exclusion criteria (7 listed)
- E1. Patient under guardianship or trusteeship.
- E2. Cancer with constitutional BRCA1/2 mutation.
- E3. Previously treated by immunomodulators (PD1/PDL1, CTLA4).
- E4. Systemic treatment by an immunosuppressor (including, but not limited to, corticosteroids, azathioprine, methotrexate, thalidomide and anti-TNF-alpha) or by an immunostimulant within 2 weeks before inclusion, except corticosteroids listed below: inhaled corticosteroids, intranasal corticosteroids, topic corticosteroids, and systemic corticosteroids with prednisone or equivalent physiological dose ≤ 10 mg/day.
- E5. Patient with known history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis,systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipids syndrome, Wegener syndrome , Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vascularitis, or glomerulonephritis, B or C hepatitis infection, HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of immune cells populations on tumour sample from exeresis
Time frame: At surgery
Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry, electrochemiluminescence and proliferation test
7 secondary outcomes
Characterization of immune cells populations on blood sample
Time frame: At surgery
Characterization of transcriptomic profile of immune cells populations
Time frame: At surgery
Characterization of molecular profile of tumor sample
Time frame: At surgery
Comparison of soluble factors of the tumor microenvironment with soluble factors present in the blood
Time frame: At surgery
Characterization of immunoglobulins and their antigenic targets
Time frame: At surgery
Characterization of TCR repertory of LT CD8+ and Tregs
Time frame: At surgery
Determination of the correlation between biological characterizations at surgery and clinical characterizations
Time frame: Up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
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 Ovarian Carcinoma and Breast Carcinoma, run by Centre Leon Berard 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Chopin (+ 33 (0)4 78 78 28 28, nicolas.chopin@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of immune cells populations on tumour sample from exeresis (time frame: At surgery). 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 27 Apr 2026.