Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation
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);
None
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.
Cohort
Prospective
Not listed
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;
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;
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;
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;
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;
Duration of the 1st line systemic chemotherapy
Duration of the 1st line systemic (postoperative) chemotherapy (months), No. of cycles of chemotherapy;
Proportion of patients with progression
Proportion of patients with progression according to RECIST 1.1 criteria;
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);
Proportion of patients underwent surgery
Proportion of patients underwent surgery overall and by each type (if applicable);
Proportion of patients received any radiation therapy
Proportion of patients received any radiation therapy (RT) overall and by each type (if applicable);
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);
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).
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