Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Hradec Kralove

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Neoadjuvant treatment

Recurrent or metastatic disease at diagnosis

Inadequate imaging or tissue samples

Cancer synchronous duplicity

Trial population

Patients with histologicaly confirmed endometrial cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    No intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The accuracy of preoperative risk stratification

Time frame
From enrollment to the first follow-up visit at 4 weeks after surgery.
2

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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