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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Arkhangelsk, Russia Recruiting
• Research Site
  Barnaul, Russia Recruiting
• Research Site
  Chelyabinsk, Russia Recruiting
• Research Site
  Irkutsk, Russia Recruiting
• Research Site
  Izhevsk, Russia Recruiting
• Research Site
  Krasnodar, Russia Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.