An observational study in Endometrial Cancer, sponsored by AstraZeneca. Recruiting at 19 sites in Russia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by AstraZeneca · Observational
Among 16 studies in Endometrial Neoplasms by AstraZeneca — 10 open to participants now, 13 under way, 4 of them phase 3. Endometrial Neoplasms · AstraZeneca.
Among the 16 studies in Endometrial Neoplasms by AstraZeneca, this one is one of 7 that started in 2025, is one of 5 observational ones, reaches primary completion later than 2 of the 12 other live ones, and was the 14th registered.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 500 is above the median of 179 across 331 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →10 of the 16 studies in Endometrial Neoplasms by AstraZeneca are open now, in 12 countries. Each count lists the studies.
Of the 359 Endometrial Neoplasms studies recruiting now, 269 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 27 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 7 started in 2025.
Median enrollment 460 across the 11 interventional studies, 140 across the 5 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
6 of the studies in Endometrial Neoplasms by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT04644068AstraZenecaStudy of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | 2027-05-28 |
| NCT07041606AstraZenecaAn Observational Study of Molecular profIling of Advanced and aggRessive ENdometrial Cancer and 1-st Line Treatment Approaches in Russian Federation | 2027-06-30 |
| NCT06218914AstraZenecaPhase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors | 2027-08-30 |
| NCT05123482AstraZenecaA Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies | 2027-09-29 |
Among the 16 studies in Endometrial Neoplasms by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Patients participating in clinical (interventional) studies since the diagnosis of confirmed, advanced EC.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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;
Time frame: 24 months
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;
Time frame: 24 months
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;
Time frame: 24 months
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;
Time frame: 24 months
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.
Time frame: 24 months
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;
Time frame: 33 months
Duration of the 1st line systemic chemotherapy
Duration of the 1st line systemic (postoperative) chemotherapy (months), No. of cycles of chemotherapy;
Time frame: 33 months
Proportion of patients with progression
Proportion of patients with progression according to RECIST 1.1 criteria;
Time frame: 33 months
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);
Time frame: 33 months
Age at the histologically confirmed diagnosis of aggressive advanced EC
Age at the histologically confirmed diagnosis of aggressive advanced Endometrial cancer
Time frame: 24 months
Proportion of patients of different races and ethnicities
Proportion of patients of different races and ethnicities
Time frame: 24 months
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;
Time frame: 24 months
Proportion of patients with a personal oncology history
Proportion of patients with a personal oncology history overall and by each disease;
Time frame: 24 months
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
Time frame: 24 months
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)
Time frame: 24 months
Proportion of patients with concomitant diseases
Proportion of patients with concomitant diseases overall and by each disease;
Time frame: 24 months
Proportion of patients receiving concomitant therapies
Proportion of patients receiving concomitant therapies overall and by each medicine (by ATC);
Time frame: 24 months
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).
Time frame: 24 months
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)
Time frame: 24 months
Proportion of patients with each histological type of tumour
Proportion of patients with each histological type of tumour
Time frame: 24 months
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;
Time frame: 24 months
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
Time frame: 24 months
Proportion of patients underwent surgery
Proportion of patients underwent surgery overall and by each type (if applicable);
Time frame: 33 months
Proportion of patients received any radiation therapy
Proportion of patients received any radiation therapy (RT) overall and by each type (if applicable);
Time frame: 33 months
Proportion of patients with each radiation area
Proportion of patients with each radiation area (if applicable) (to be calculated in patients who received any RT);
Time frame: 33 months
Total RT dose (Gy) by each radiation area
Total radiation therapy (RT) dose (Gray) by each radiation area (to be calculated in patients who received any RT).
Time frame: 33 months
Proportion of patients with several biomarkers present at the same time
Proportion of patients with several biomarkers present at the same time, for example, two, three, four, etc. including positive status for POLEm / dMMR/pMMR / p53abn / PD-L1 and positive HER2 expression.
Time frame: 24 months
Not enrolling at this site.
Plan to share: 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.
Supporting information: Clinical study report
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.
Of 150 observational studies under Endometrial Neoplasms, half reached primary completion within 105 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 207. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.