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

AstraZeneca

Status: Enrolling

Conditions: Endometrial Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07041606

D0817R00117

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.