Endometrial Cancer
Conditions
Brief summary
Multicenter, observational, prospective study of molecular profiling in advanced and aggressive endometrial cancer patients and 1-st line treatment approaches in Russian Federation
Detailed 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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of HER2 expression 3+ detected by IHC | 24 months | 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. |
| The rate of POLEm positive status | 24 months | 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 | 24 months | 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 | 24 months | 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 | 24 months | The rate of Programmed Cell Death Ligand 1 positive status (Tumor Area Positivity ≥1%) detected by Immunohistochemistry; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with progression | 33 months | Proportion of patients with progression according to RECIST 1.1 criteria; |
| Median time from advanced EC diagnosis to progression | 33 months | 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); |
| Age at the histologically confirmed diagnosis of aggressive advanced EC | 24 months | Age at the histologically confirmed diagnosis of aggressive advanced Endometrial cancer |
| Proportion of patients of different races and ethnicities | 24 months | Proportion of patients of different races and ethnicities |
| Proportion of patients with presence of a family oncology history | 24 months | Proportion of patients with presence of a family oncology history (in first-degree relatives) overall and by each disease; |
| Proportion of patients with a personal oncology history | 24 months | Proportion of patients with a personal oncology history overall and by each disease; |
| Proportion of patients with presence of EC development risk factors | 24 months | 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 |
| Proportion of patients with each category by ECOG assessment | 24 months | 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) |
| Proportion of patients with concomitant diseases | 24 months | Proportion of patients with concomitant diseases overall and by each disease; |
| Proportion of patients receiving concomitant therapies | 24 months | Proportion of patients receiving concomitant therapies overall and by each medicine (by ATC); |
| Proportion of patients with each clinical stage | 24 months | 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). |
| Proportion of patients with each histological type of tumour | 24 months | Proportion of patients with each histological type of tumour |
| Proportion of patients with each clinical stage by FIGO classification | 24 months | 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) |
| Proportion of patients with each category by grade of differentiation | 24 months | Proportion of patients with each category by grade of tumor differentiation from G1 (high grade) - highly differentiated) to G3 (low grade) - poorly differentiated; |
| The rate of each diagnostic methods used in a routine practice in the diagnostics process of EC | 24 months | The rate of each diagnostic methods used in a routine practice in the diagnostics process of Endometrial cancer |
| Proportion of patients received any 1st line systemic (postoperative) chemotherapy | 33 months | Proportion of patients received any 1st line systemic (postoperative) chemotherapy, overall and by each regimen/drug; |
| Duration of the 1st line systemic chemotherapy | 33 months | Duration of the 1st line systemic (postoperative) chemotherapy (months), No. of cycles of chemotherapy; |
Countries
Russia
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed