Endometrial CancerNCT06273878
From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
An observational study of Endometrial Cancer, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial summary
Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Jan 2023to 15 Jan 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: The population is represented by patients with endometrial cancer who have undergone, or who have will undergo surgery
Who may be able to join
- Age >18 years;
- Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid 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 that are subjected to surgery;
- Adequate biological material to be able to carry out the analyzes previously described;
- Written informed consent (only for patients in the prospective part and/or in follow-up);
- For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data.
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
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
National Cancer Institute - IFO -
Rome, RM, 00144
Benito Chiofalo, Doctor, ND, benito.chiofalo@ifo.gov.it
Valentina Bruno, Doctor, ND, valentina.bruno@ifo.gov.it
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Benito Chiofalo, Doctor, ND, benito.chiofalo@ifo.it
Valentina Bruno, Doctor, ND, valentina.bruno@ifo.gov.it
About this study
Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.
Read the detailed description
The picture of precisely coordinated immune adaptations over time at the maternal-fetal interface level and altered in pregnancy complications, could reveal a specific "immune clock" in tumors. The study aims to decipher mechanisms of immunodeficiency by helping to predict recurrence in patients with endometrial cancer and identify molecular pathways that are turned on or off in progression from lesions early to advanced neoplasia. This will allow the discovery of potential immunotherapy targets to interfere with the immune escape activation process or to reactivate/re-educate the immune response.
- Conditions
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the differential expression of LOX-1 and NALP3 receptors.
Validate the differential expression of LOX-1 and NALP3 receptors at different steps progression of endometrial cancer; identify immune signatures shared between using transcriptomics the maternal-fetal interface and the different stages of progression of endometrial cancer; investigate their role functional in the immune escape process in endometrial carcinoma and/or in the pro-inflammatory response.
Measured: 36 months
Secondary outcomes (2)
Characterize phenotypic alterations.
Characterize the phenotype and functional alterations of multiple candidate biomarkers relevant selected in AIM1 (surface antigens / cytokines / molecular pathways), a level of the cells of the immune infiltrate, in the different stages of cancer progression to the endometrium.
Measured: 36 months
Evaluate the predictive and/or prognostic value.
Evaluate the predictive and/or prognostic value of the immuno-score deriving from the data of Aim 1 and Aim 2 alone or in combination with clinical and prognostic risk factors known histopathological findings, expressed in the ESMO-ESGO-ESTRO consensus conference.
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 posted23 Feb 2024
- Study start15 Jan 2023
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273878
- Sponsor's protocol ID
- RS1439/20
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
- ClinicalTrials.gov ID
- NCT06273878
- Acronym / sponsor ID
- RS1439/20
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 23 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.
Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.
Detailed description
The picture of precisely coordinated immune adaptations over time at the maternal-fetal interface level and altered in pregnancy complications, could reveal a specific "immune clock" in tumors. The study aims to decipher mechanisms of immunodeficiency by helping to predict recurrence in patients with endometrial cancer and identify molecular pathways that are turned on or off in progression from lesions early to advanced neoplasia. This will allow the discovery of potential immunotherapy targets to interfere with the immune escape activation process or to reactivate/re-educate the immune response.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is represented by patients with endometrial cancer who have undergone, or who have will undergo surgery
Key inclusion criteria (5 listed)
- Age >18 years;
- Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid 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 that are subjected to surgery;
- Adequate biological material to be able to carry out the analyzes previously described;
- Written informed consent (only for patients in the prospective part and/or in follow-up);
- For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data.
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.
Primary outcome
Validate the differential expression of LOX-1 and NALP3 receptors.
Time frame: 36 months
Validate the differential expression of LOX-1 and NALP3 receptors at different steps progression of endometrial cancer; identify immune signatures shared between using transcriptomics the maternal-fetal interface and the different stages of progression of endometrial cancer; investigate their role functional in the immune escape process in endometrial carcinoma and/or in the pro-inflammatory response.
2 secondary outcomes
Characterize phenotypic alterations.
Time frame: 36 months
Evaluate the predictive and/or prognostic value.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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.
2 sites 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 2 sites 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 5 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Benito Chiofalo, Doctor (ND, benito.chiofalo@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the differential expression of LOX-1 and NALP3 receptors. (time frame: 36 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 23 Feb 2024.