Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging

NCT07368205 | Not Yet Recruiting

• 1 other identifier: 202511P08
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to evaluaty the accuracy of current risk stratification of patients with endometrial cancer and to redefine lymph node staging recommendations based on real-world clinical data. The main question it aims to answer is: Is there any group of patients who doesn't need lymph node staging for proper indication of adjuvant treatment? Participants are note taking any intervention. They are treated according to current standard of care and followed 3-years after primary surgery.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; molecular classification; expert ultrasonography; lymph node staging

Outcome Measures

Primary Outcomes (2)

• The accuracy of preoperative risk stratification

  From enrollment to the first follow-up visit at 4 weeks after surgery.

• Determination of specific groups for whom: 1) lymph node staging is crucial for changing risk category and adjuvant treatment decisions, and 2) lymph node staging could be safely omitted

  From enrollment to the first follow-up visit at 4 weeks after surgery.

Interventions

No Intervention: Observational Cohort OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologicaly confirmed endometrial cancer.

You may qualify if:

• Women ≥18 years with newly diagnosed endometrial cancer (any histology)
• Undergoing primary surgical management
• Preoperative expert ultrasound, CT scan (could be waived in low risk cases)
• Preoperatively early-stage (stage I-II) of EC
• SLN mapping attempted intraoperatively
• FFPE tumor tissue available for molecular and IHC testing from biopsy
• Signed informed consent with the participation in the study

You may not qualify if:

• Neoadjuvant treatment
• Recurrent or metastatic disease at diagnosis
• Inadequate imaging or tissue samples
• Cancer synchronous duplicity
• Prior oncological treatment within the last five years

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Biospecimen

Retention: SAMPLES WITH DNA

preoperative biopsy specimen - endometrial tissue

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 26, 2026

Record last verified: 2026-01