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Endometrial CancerIRENNCT07041606

An Observational Study of Molecular profIling of Advanced and aggRessive ENdometrial Cancer and 1-st Line Treatment Approaches in Russian Federation

An observational study of Endometrial Cancer, run by AstraZeneca at 19 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
How many people
500 participants
Where
19 sitesRussia
Study dates
24 Jun 2025to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Study population will consist of patients with newly diagnosed aggressive subtypes of advanced (III-IV stages) EC, with available medical history, biopsy or post-operative archival FFPE tumor samples (blocks). It is estimated that approximately 500 patients will be enrolled in about 30 sites.

Who may be able to join

  • Female patients aged ≥ 18 years old;
  • Signed ICF, including consent for archival FFPE tumor tissue block testing;
  • Newly diagnosed, histologically confirmed, advanced (III-IV stage) EC, with the date of diagnosis of histologically confirmed disease within 4 months before inclusion;
  • 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);
  • The presence of biopsy or postoperative archival FFPE tumor sample (block);
  • Availability of source medical documentation.

Who cannot join

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

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

19 sites in 1 country

Russia19 sites, 18 recruiting

  • Research Site

    Arkhangelsk

    Recruiting

  • Research Site

    Barnaul

    Recruiting

  • Research Site

    Chelyabinsk

    Recruiting

  • Research Site

    Irkutsk

    Recruiting

  • Research Site

    Izhevsk

    Recruiting

  • Research Site

    Krasnodar

    Recruiting

  • Research Site

    Krasnoyarsk

    Recruiting

  • Research Site

    Moscow

    Recruiting

  • Research Site

    Murmansk

    Recruiting

  • Research Site

    Obninsk

    Not yet recruiting

  • Research Site

    Saint Petersburg

    Recruiting

  • Research Site

    Severodvinsk

    Not yet recruiting

  • Research Site

    Sochi

    Recruiting

  • Research Site

    Tomsk

    Recruiting

  • Research Site

    Tver'

    Recruiting

  • Research Site

    Ufa

    Recruiting

  • Research Site

    Vladivostok

    Withdrawn

  • Research Site

    Yaroslavl

    Recruiting

  • Research Site

    Yekaterinburg

    Recruiting

Other trials in Russia

About this study

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

Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation

Read the detailed description

This study is national, multi-center, prospective, cohort study to collect real world data of endometrial cancer patients with aggressive advanced (stage III-IV) disease, prevalence of POLEm, dMMR/pMMR, p53abn, HER2, PD-L1, demographic and clinical characteristics and 1-st line (postoperative) treatment approaches in Russian Federation. The study will sequentially include only those patients who have signed the informed consent form (ICF). No additional procedures besides those already used in the routine clinical practice will be applied to the patients.

Study population will consist of patients with newly diagnosed aggressive subtypes of advanced (III-IV stages) EC, with available medical history, biopsy or post-operative archival FFPE tumor samples (blocks). It is estimated that approximately 500 patients will be enrolled in about 30 sites.

In the study there will be two visits carried out according to routine clinical practice. At baseline visit (visit 1) demographic and clinical characteristics and treatment approaches from the date of newly diagnosed advanced (III-IV stages) EC of aggressive subtype will be collected based on the patient's medical records. In case of absence of data required to be collected by the protocol, additional data may be obtained during patient's interview directly and recorded in the source documents related to the visit. For POLEm, dMMR/pMMR, p53abn, HER2, PD-L1 testing, biopsy or post-operative archival FFPE tumor sample (block), will be used. Testing will be performed using immunohistochemistry (IHC) (for MMR, p53, HER2, PD-L1) and next-generation sequencing (NGS) or polymerase chain reaction (PCR) (for POLEm) in central laboratories.

Visit 2 (final visit) will be conducted in 6 months after baseline (±6 weeks) or at progression of the disease (whichever comes first) to collect follow-up data on treatment approaches, and progression (if applicable).

All study data will be entered into electronic case report form (eCRF). The study physician will be responsible for ensuring that all required data is collected and entered into the eCRF.

Overall expected duration of the study (from the first patient inclusion to the final database lock) is about 27 months, or until 500 eligible patients are included to the study and data on these patients are collected (including follow-up data), whichever occurs first.

Medical subject headings
Endometrial Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of POLEm positive status

    The rate of Mutation in the exonuclease domain of the Deoxyribonucleic Acid polymerase epsilon (POLE) gene positive status (i.e. detection of pathological variant(s) by Next-Generation Sequencing /Polymerase Chain Reaction), overall and by each variant;

    Measured: 24 months

  2. The rate of dMMR status and pMMR status detected by IHC and by combined approach of molecular classification

    The rate of Mismatch Repair Deficiency status and Mismatch Repair Proficiency status detected by Immunohistochemistry and by combined approach of molecular classification;

    Measured: 24 months

  3. The rate of p53abn positive status detected by IHC and by combined approach of molecular classification

    The rate of Abnormal expression of p53 protein positive status detected by Immunohistochemistry and by combined approach of molecular classification;

    Measured: 24 months

  4. The rate of PD-L1 positive status detected by IHC

    The rate of Programmed Cell Death Ligand 1 positive status (Tumor Area Positivity ≥1%) detected by Immunohistochemistry;

    Measured: 24 months

  5. The rate of HER2 expression 3+ detected by IHC

    The rate of HER2 expression 3+ detected by Immunohistochemistry according to American Society of Clinical Oncology College of American Pathologists (ASCO CAP) gastric cancer and ASCO CAP guidelines for HER2 testing in Endometrial cancer, and proportion of patients with each result of Immunohistochemistry score (0, 1+, 2+, 3+) on each of the two criteria of evaluation and relationship between them.

    Measured: 24 months

Secondary outcomes (17)

  1. Proportion of patients received any 1st line systemic (postoperative) chemotherapy

    Proportion of patients received any 1st line systemic (postoperative) chemotherapy, overall and by each regimen/drug;

    Measured: 33 months

  2. Duration of the 1st line systemic chemotherapy

    Duration of the 1st line systemic (postoperative) chemotherapy (months), No. of cycles of chemotherapy;

    Measured: 33 months

  3. Proportion of patients with progression

    Proportion of patients with progression according to RECIST 1.1 criteria;

    Measured: 33 months

  4. Median time from advanced EC diagnosis to progression

    Median time from advanced EC diagnosis to progression (calculated between the date of histologically confirmed advanced EC diagnosis and the date of EC progression according to RECIST 1.1 criteria);

    Measured: 33 months

  5. Age at the histologically confirmed diagnosis of aggressive advanced EC

    Age at the histologically confirmed diagnosis of aggressive advanced Endometrial cancer

    Measured: 24 months

  6. Proportion of patients of different races and ethnicities

    Proportion of patients of different races and ethnicities

    Measured: 24 months

  7. Proportion of patients with presence of a family oncology history

    Proportion of patients with presence of a family oncology history (in first-degree relatives) overall and by each disease;

    Measured: 24 months

  8. Proportion of patients with a personal oncology history

    Proportion of patients with a personal oncology history overall and by each disease;

    Measured: 24 months

  9. Proportion of patients with presence of EC development risk factors

    Proportion of patients with presence of EC development risk factors:

    • Obesity (physician-diagnosed or based on BMI>30 kg/m2), current of in the past
    • Smoking status
    • Early menarche (before 12 years)
    • Late menopause (after 55 years)
    • Endometrial hyperplasia
    • Nulliparity

    Measured: 24 months

  10. Proportion of patients with each category by ECOG assessment

    Proportion of patients with each category by Eastern Cooperative Oncology Group assessment at the inclusion, grades from 0 (Fully active, able to carry on all pre-disease performance without restriction) to 5 (Dead)

    Measured: 24 months

  11. Proportion of patients with concomitant diseases

    Proportion of patients with concomitant diseases overall and by each disease;

    Measured: 24 months

  12. Proportion of patients receiving concomitant therapies

    Proportion of patients receiving concomitant therapies overall and by each medicine (by ATC);

    Measured: 24 months

  13. Proportion of patients with each clinical stage

    Proportion of patients with each clinical stage by TNM (a standard method for classifying the extent of malignant tumors) classification. The size and extent of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N), and whether the cancer has metastasized to distant parts of the body (M).

    Measured: 24 months

  14. Proportion of patients with each clinical stage by FIGO classification

    Proportion of patients with each clinical stage by FIGO (The International Federation of Gynecology and Obstetrics (Fédération Internationale de Gynécologie et d'Obstétrique)) classification. FIGO stages are from I (Tumor confined to the corpus uteri) to IVB (Distant metastases, including intra-abdominal metastases and/or inguinal lymph nodes)

    Measured: 24 months

  15. Proportion of patients with each histological type of tumour

    Proportion of patients with each histological type of tumour

    Measured: 24 months

  16. Proportion of patients with each category by grade of differentiation

    Proportion of patients with each category by grade of tumor differentiation from G1 (high grade) - highly differentiated) to G3 (low grade) - poorly differentiated;

    Measured: 24 months

  17. The rate of each diagnostic methods used in a routine practice in the diagnostics process of EC

    The rate of each diagnostic methods used in a routine practice in the diagnostics process of Endometrial cancer

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start24 Jun 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07041606
Sponsor's protocol ID
D0817R00117
Acronym
IREN
Status last verified
Sep 2026
First submitted
6 Jun 2025
Last updated
8 Sep 2026
Results posted
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer, run by AstraZeneca at 19 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of POLEm positive status (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07041606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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