Endometrial CancerNCT05793333
Predictors of Node Positivity in Endometrial Cancer
An observational study of Endometrial Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer 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
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 1 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: Patietns were submitted to standard treatment modality for managing endometrial cancer. They will receive hsyterectomy (with or without bilateral salpingo-oophorectomy) plus sentinel ndoe mapping. After the procedures data regarding hystologcial charactersitcs of the tumor and molecular features will be analyzed (as routine cliical practice). We will correlate those data with findings achieved by sentinel nodes
Who may be able to join
- Written informed consent
- Histologically confirmed endometrila cancer
- Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
- Data on histological characteristics of the ttumor
- Execution of sentinel node mapping
- Data on sentinel node status (negative vs. positive)
Who cannot join
- Stage IVB endoemtrial cancer
- consent withdraw
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20148
Giorgio Bogani, +393803933116, giorgiobogani@yahoo.it
Valentina Chiappa, MD, +0223901, valentina.chiappa@istitutotumori.mi.it
About this study
Official title: Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study
To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.
- Conditions
- Endometrial Cancer
- Keywords
- sentinel node, endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
positive nodes
positive nodes detected by sentinel node mappinig
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start10 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Chiappa, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Giorgio Bogani, MD, Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793333
- Sponsor's protocol ID
- 142020
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bogani G, Lalli L, Casarin J, Ghezzi F, Chiappa V, Fanfani F, Scambia G, Raspagliesi F. Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial. Int J Gynecol Cancer. 2024 Sep 2;34(9):1366-1372. doi: 10.1136/ijgc-2024-005416.
PubMed 38658017
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study
- ClinicalTrials.gov ID
- NCT05793333
- Acronym / sponsor ID
- 142020
- Conditions
- Endometrial Cancer
- Keywords
- sentinel node, endometrial cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 31 Mar 2023 (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.
To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patietns were submitted to standard treatment modality for managing endometrial cancer. They will receive hsyterectomy (with or without bilateral salpingo-oophorectomy) plus sentinel ndoe mapping. After the procedures data regarding hystologcial charactersitcs of the tumor and molecular features will be analyzed (as routine cliical practice). We will correlate those data with findings achieved by sentinel nodes
Key inclusion criteria (6 listed)
- Written informed consent
- Histologically confirmed endometrila cancer
- Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
- Data on histological characteristics of the ttumor
- Execution of sentinel node mapping
Key exclusion criteria (2 listed)
- Stage IVB endoemtrial cancer
- consent withdraw
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
positive nodes
Time frame: 12 months
positive nodes detected by sentinel node mappinig
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38658017Bogani G, Lalli L, Casarin J, Ghezzi F, Chiappa V, Fanfani F, Scambia G, Raspagliesi F. Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial. Int J Gynecol Cancer. 2024 Sep 2;34(9):1366-1372. doi: 10.1136/ijgc-2024-005416.
- 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.
Giorgio Bogani, MD study chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 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 6 inclusion and 2 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 19 Sep 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 Grazia M Casadei, ph.d. (917-275-6975, grazia.casadei@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive nodes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793333, which also lists 1 linked publication.
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 19 Sep 2024.