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Molecular profiling and first-line treatment patterns for advanced aggressive endometrial cancer in Russia

Multicenter, Observational, Prospective Study of Molecular Profiling in Advanced and Aggressive Endometrial Cancer Patients and 1-st Line Treatment Approaches in Russian Federation

Observational AstraZeneca · NCT07041606

This project will collect tumor molecular profiles and first-line treatment information from people in Russia with newly diagnosed advanced, aggressive endometrial cancer to see which molecular changes are common and how patients are being treated.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexFemale
SponsorAstraZeneca Industry-sponsored
Locations21 sites (Arkhangelsk and 20 other locations)
Trial IDNCT07041606 on ClinicalTrials.gov

What this trial studies

This is a national, multicenter prospective cohort collecting real-world data on about 500 women with newly diagnosed advanced (FIGO III–IV) aggressive endometrial cancer across roughly 30 Russian sites. Demographic and clinical data will be captured from medical records and patient interviews during routine care visits, and archival FFPE tumor blocks will be tested for POLE mutations, MMR status (dMMR/pMMR), p53 abnormalities, HER2, and PD-L1. Only procedures already used in routine practice will be applied and there are two visits aligned with standard care. Patients enrolled must provide informed consent and those participating in interventional trials since diagnosis are excluded.

Who should consider this trial

Good fit: Adult women (≥18 years) in the Russian Federation with newly diagnosed, histologically confirmed advanced (stage III–IV) aggressive endometrial cancer who can provide informed consent and have an available archival FFPE tumor block are ideal candidates.

Not a fit: Patients in concurrent interventional clinical trials, those without available FFPE tumor tissue, or those with early-stage disease (I–II) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help tailor treatment approaches and inform future clinical trials by revealing the distribution of molecular subtypes and current first-line care patterns in Russia.

How similar studies have performed: Previous molecular classification efforts (for example TCGA and ProMisE frameworks) have demonstrated that POLE, MMR, and p53 markers are informative for endometrial cancer biology, though large real-world registries in Russia are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Female patients aged ≥ 18 years old;
2. Signed ICF, including consent for archival FFPE tumor tissue block testing;
3. Newly diagnosed, histologically confirmed, advanced (III-IV stage) EC, with the date of diagnosis of histologically confirmed disease within 4 months before inclusion;
4. Endometrioid type G3 or any non-endometrioid histological type of EC (such as serous carcinoma, clear cell carcinoma, mixed carcinoma, undifferentiated and dedifferentiated carcinoma, carcinosarcoma, others);
5. The presence of biopsy or postoperative archival FFPE tumor sample (block);
6. Availability of source medical documentation.

Exclusion Criteria:

1\. Patients participating in clinical (interventional) studies since the diagnosis of histologically confirmed, advanced EC.

Where this trial is running

Arkhangelsk and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.