Predictors of Node Positivity in Endometrial Cancer

NCT ID: NCT05793333

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-10

Study Completion Date

2025-01-01

Brief Summary

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To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.

Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Stage IVB endoemtrial cancer
* consent withdraw
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role lead

Responsible Party

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Valentina Chiappa

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giorgio Bogani, MD

Role: STUDY_CHAIR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Grazia M Casadei, ph.d.

Role: CONTACT

917-275-6975

Facility Contacts

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Giorgio Bogani

Role: primary

+393803933116

Valentina Chiappa, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38658017 (View on PubMed)

Other Identifiers

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142020

Identifier Type: -

Identifier Source: org_study_id

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