Endometrial CancerNCT06250010
Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological Profiling of the Tumor Microenvironment in Risk Stratification of Recurrence
An observational study of Endometrial Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
This pilot/exploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute, IRE - IFO and stored at the Biobank of same Institute (BBIRE) (cohort 1) and on samples of decidualized… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 13 Dec 2022to 13 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Oncology patients who have undergone or will undergo to surgery. And patients with ongoing miscarriage who do will undergo surgery.
Who may be able to join
- Cohort 1: Oncology patients
- Age >18 years
- Histological diagnosis of endometrial hyperplasia with and without atypia, endometrial carcinoma endometrioid histotype at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma who undergo surgery;
- Adequate biological material to be able to carry out the planned analyses;
- Written informed consent (only for patients in the prospective part and/or in follow up/traceable);
- For the retrospective part: availability of samples adequately stored at the biobank of the Institute and availability of data relating to follow-up (at least 36 months).
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- Cohort 2: Patients with ongoing spontaneous abortion
- Age >18 years;
- Diagnosis of ongoing spontaneous abortion which is subjected to an instrumental review procedure of the uterine cavity, under hysteroscopic guidance;
- Adequate biological material to be able to carry out the analyzes previously described;
- Written informed consent.
Who cannot join
- Comorbidities not controlled with adequate medical therapy;
- Infections of the endometrial cavity (pyometra);
- Synchronous tumors;
- Neoadjuvant treatments;
- Previous radiation treatments on the pelvic region.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Valentina Bruno, Doctor, nd, valentina.bruno@ifo.gov.it
About this study
Official title: Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological
This pilot/exploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute, IRE - IFO and stored at the Biobank of same Institute (BBIRE) (cohort 1) and on samples of decidualized endometrium and trophoblast from patients with ongoing spontaneous abortion treated surgically at the UOC of Gynecology ed Obstetrics of the Federico II University Polyclinic of Naples (cohort 2)
Read the detailed description
For the experiments proposed in the project the following will be used:
Court 1: tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective); Court 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transfer to the Regina National Cancer Institute Elena, IRE-IFO.
Clinical data
The following data will be collected for each patient:
- Age, ethnicity, parity, luxury habits, level of education, marital status, height, weight, index of body mass
- Data on previous clinical history, previous gynecological-obstetric pathologies and any treatments, current comorbidities and medical therapies
For Cohort1 patients only:
- Data relating to the neoplastic pathology: histotype, grading, FIGO stage
- Data on oncological follow-up: any intra- or post-operative complications, any therapies adjuvants, type and data of any recurrence/metastasis, type of treatment if any recurrence, date and manner of death.
- Conditions
- Endometrial Cancer
- Being tested
- tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)Diagnostic test
Correlation between the immuno-score results of each patient with his prognosis, in terms disease-free survival, overall survival, relapse-free survival, disease-specific survival cancer, distant and/or local free survival, to validate their potential role independent in the progression of endometrial cancer; later, for a better characterization of the various ones risk classes, we will combine our immuno-score with the already known risk factors, included in the ESMO-ESGO-ESTRO classification and in the biomolecular classification of endometrial cancer, to investigate whether the Microenvironmental immunological factors in endometrial cancer could allow better stratification of patients in risk classes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: tissue samples (healthy and tumor taken from the same patient) | Tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective). The data relating to the neoplastic pathology will also be indicated: histotype, grading, FIGO stage. And data on oncological follow-up: any intra or post-operative complications, any adjuvant therapies, type and date of any recurrence/metastasis, type of treatment, any recurrence, date and manner of death Receives: Diagnostic Test: tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient) | |
| Cohort 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) | The tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected from the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transferred to the Regina National Cancer Institute Elena, IRE-IFO Receives: Diagnostic Test: tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of genetic signatures shared between the maternal-fetal interface
The trial aims to describe gene signatures shared between the maternal-fetal interface and the various stages of progression of endometrial carcinoma, through transcriptomic analysis, with the aim of evaluate their functional role in the immune escape of endometrial carcinoma.Transcriptomics (RNA-seq) coupled with will be used imaging approaches (IHC) and digital pathology. Spatial techniques will be exploited transcriptomics coupled to single-cell RNA-seq to study interactions between cells in the TME and at the maternal-fetal interface. The results of each patient's immuno-score will be correlated with his prognosis, in terms disease-free survival, overall survival, relapse-free survival, disease-specific survival cancer, distant and/or local free survival, to validate their potential role independent in the progression of endometrial cancer.
Measured: 36 months
Calculation of potential immuno-score
Calculation of potential immuno-score for each patient, considering immune pathways, correlating the results of each patient's immuno-score with his prognosis, in terms disease-free survival and overall survival.
Measured: 36 months
characterize the risk classes
To characterize the various risk classes, the immuno-score will be combined with the already known risk factors, included in the ESMO-ESGO-ESTRO classification and in the biomolecular classification of endometrial carcinoma, to investigate whether the Microenvironmental immunological factors in endometrial cancer might allow for better stratification of patients in risk classes, with the use of Artificial Intelligence, such as Machine Learning and neural networks.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start13 Dec 2022
- Primary completion13 Dec 2025 (estimated)
- Study completion13 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
- Investigators
- Valentina Bruno, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250010
- Sponsor's protocol ID
- RS1807/22
- Status last verified
- May 2024
- First submitted
- 16 Jan 2024
- Last updated
- 31 May 2024
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological
- ClinicalTrials.gov ID
- NCT06250010
- Acronym / sponsor ID
- RS1807/22
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 13 Dec 2025 (estimated)
- Study completion
- 13 Dec 2025 (estimated)
- First posted
- 8 Feb 2024 (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 pilot/exploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute, IRE - IFO and stored at the Biobank of same Institute (BBIRE) (cohort 1) and on samples of decidualized endometrium and trophoblast from patients with ongoing spontaneous abortion treated surgically at the UOC of Gynecology ed Obstetrics of the Federico II University Polyclinic of Naples (cohort 2)
Detailed description
For the experiments proposed in the project the following will be used:
Court 1: tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective); Court 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transfer to the Regina National Cancer Institute Elena, IRE-IFO.
Clinical data
The following data will be collected for each patient:
- Age, ethnicity, parity, luxury habits, level of education, marital status, height, weight, index of body mass
- Data on previous clinical history, previous gynecological-obstetric pathologies and any treatments, current comorbidities and medical therapies
For Cohort1 patients only:
- Data relating to the neoplastic pathology: histotype, grading, FIGO stage
- Data on oncological follow-up: any intra- or post-operative complications, any therapies adjuvants, type and data of any recurrence/metastasis, type of treatment if any recurrence, date and manner of death.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: tissue samples (healthy and tumor taken from the same patient) | – | Diagnostic Test: tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)Tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective). The data relating to the neoplastic pathology will also be indicated: histotype, grading, FIGO stage. And data on oncological follow-up: any intra or post-operative complications, any adjuvant therapies, type and date of any recurrence/metastasis, type of treatment, any recurrence, date and manner of death |
| Cohort 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) | – | Diagnostic Test: tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)The tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected from the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transferred to the Regina National Cancer Institute Elena, IRE-IFO |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology patients who have undergone or will undergo to surgery. And patients with ongoing miscarriage who do will undergo surgery.
Key inclusion criteria (11 listed)
- Cohort 1: Oncology patients
- Age >18 years
- Histological diagnosis of endometrial hyperplasia with and without atypia, endometrial carcinoma endometrioid histotype at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma who undergo surgery;
- Adequate biological material to be able to carry out the planned analyses;
- Written informed consent (only for patients in the prospective part and/or in follow up/traceable);
Key exclusion criteria (5 listed)
- Comorbidities not controlled with adequate medical therapy;
- Infections of the endometrial cavity (pyometra);
- Synchronous tumors;
- Neoadjuvant treatments;
- Previous radiation treatments on the pelvic region.
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 |
|---|---|---|
| tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)Correlation between the immuno-score results of each patient with his prognosis, in terms disease-free survival, overall survival, relapse-free survival, disease-specific survival cancer, distant and/or local free survival, to validate their potential role independent in the progression of endometrial cancer; later, for a better characterization of the various ones risk classes, we will combine our immuno-score with the already known risk factors, included in the ESMO-ESGO-ESTRO classification and in the biomolecular classification of endometrial cancer, to investigate whether the Microenvironmental immunological factors in endometrial cancer could allow better stratification of patients in risk classes. | Diagnostic test | Cohort 1: tissue samples (healthy and tumor taken from the same patient), Cohort 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) |
Primary outcome
Description of genetic signatures shared between the maternal-fetal interface
Time frame: 36 months
The trial aims to describe gene signatures shared between the maternal-fetal interface and the various stages of progression of endometrial carcinoma, through transcriptomic analysis, with the aim of evaluate their functional role in the immune escape of endometrial carcinoma.Transcriptomics (RNA-seq) coupled with will be used imaging approaches (IHC) and digital pathology. Spatial techniques will be exploited transcriptomics coupled to single-cell RNA-seq to study interactions between cells in the TME and at the maternal-fetal interface. The results of each patient's immuno-score will be correlated with his prognosis, in terms disease-free survival, overall survival, relapse-free survival, disease-specific survival cancer, distant and/or local free survival, to validate their potential role independent in the progression of endometrial cancer.
Calculation of potential immuno-score
Time frame: 36 months
Calculation of potential immuno-score for each patient, considering immune pathways, correlating the results of each patient's immuno-score with his prognosis, in terms disease-free survival and overall survival.
characterize the risk classes
Time frame: 36 months
To characterize the various risk classes, the immuno-score will be combined with the already known risk factors, included in the ESMO-ESGO-ESTRO classification and in the biomolecular classification of endometrial carcinoma, to investigate whether the Microenvironmental immunological factors in endometrial cancer might allow for better stratification of patients in risk classes, with the use of Artificial Intelligence, such as Machine Learning and neural networks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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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.
Valentina Bruno, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
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 Endometrial Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
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 11 inclusion and 5 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 31 May 2024. 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 Italy. 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 Valentina Bruno, Doctor (nd, valentina.bruno@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of genetic signatures shared between the maternal-fetal interface (time frame: 36 months). The study lists 3 primary outcomes in all. 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 31 May 2024.