Clinical trial · Observational
An Observational Study of Molecular profIling of Advanced and aggRessive ENdometrial Cancer 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
NCT07041606CI-TRIAL-00121323IRENrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- The rate of POLEm positive status
- timeFrame
- 24 months
- description
- 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;
- measure
- The rate of dMMR status and pMMR status detected by IHC and by combined approach of molecular classification
- timeFrame
- 24 months
- description
- The rate of Mismatch Repair Deficiency status and Mismatch Repair Proficiency status detected by Immunohistochemistry and by combined approach of molecular classification;
- measure
- The rate of p53abn positive status detected by IHC and by combined approach of molecular classification
- timeFrame
- 24 months
- description
- The rate of Abnormal expression of p53 protein positive status detected by Immunohistochemistry and by combined approach of molecular classification;
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.