NCT06584630

Brief Summary

Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

July 4, 2024

Last Update Submit

September 11, 2024

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • Multidisciplinary Team Board decision change

    MDT decision for adjuvant treatment (Rate of adjuvant treatment change)

    2 years (study completion)

Study Arms (1)

endometrial cancer patients that underwent molecular classification

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endometrial cancer patients that underwent surgery and were tested for molecular analysis (POLE, MSI, p53)

You may qualify if:

  • Histological confirmation of endometrial cancer.
  • Surgical treatment at our Gynecological - Oncology Unit.

You may not qualify if:

  • Refusal to be tested for the molecular classification
  • Presence of a synchronous neoplasm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of Obstetrics & Gynecology, AUTh, "Papageorgiou" Hospital

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 4, 2024

First Posted

September 5, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)