endometrial cancer
Conditions
Interventions
None listed
Sponsors
Kitagawa Hiroshi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age>=18, Japanese women at initial diagnosis of EC 2. Patients who provided written informed consent (In deceased or untraceable cases, optout will be applicable, if accepted at the site and approved by Ethics Committee) 3. Patients who have newly diagnosed FIGO stage III/IV according to FIGO2008 or recurrent EC at the index date (patients with stage III will be eligible only if they have residual disease after surgery) 4. Patients pathologically confirmed as EC (including carcinosarcoma) at the site 5. Patients who have archived formalin-fixed paraffin-embedded (FFPE) specimens of primary tumor site meeting all of the following conditions: I. Collected prior to chemotherapy administration II. Collected within a maximum of 2 years and 9 months prior to enrolment III. Sufficient amount for submission to the testing company specified as per protocol 6. Patients who received at least one dose of first-line treatment including adjuvant chemotherapy 7. Patients who obtain all results of MMR status, POLE mutation and p53 abnormal expression by central examination
Exclusion criteria
Exclusion criteria: 1. Patients who concurrently have malignant neoplastic diseases other than EC at first-line treatment initiation of EC 2. Patients who were pathologically diagnosed as sarcoma uteri 3. Patients who received combination therapy of immune checkpoint inhibitors and chemotherapy, olaparib, or anti-HER2 antibody drug conjugates (including trastuzumab deruxtecan) 4. Patients who received any investigational drug in first-line treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.POLEmut The proportion of POLEmut determined by Next Generation Sequencing (NGS) analysis will be calculated as below. (the number of patients who are positive in POLEmut) / (the number of FAS). 2.p53abn The proportion of p53abn will be calculated as below. (the number of patients who are positive in p53abn) / (the number of FAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.MSI status The proportion of MSI-H will be calculated as below. (the number of patients who are in MSI-H) / (the number of FAS). 2.HRR The proportion of HRRm will be calculated as below. (the number of patients with HRRm) / (the number of FAS). 3.PD-L1 expression The proportion of PD-L1 will be calculated as below. (the number of patients who are PD-L1 positive) / (the number of FAS). 4.B7-H4 The proportion of B7-H4 will be calculated as below. (the number of patients who are B7-H4 positive) / (the number of FAS). 5.PFS PFS will be defined as the time from the index date to date of clinical progressive disease(PD) or death, whichever is earlier. | — |
Contacts
Public ContactYuko Hayashi
AstraZeneca K.K.
Outcome results
None listed