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The study evaluates the level and molecular profiles of different CTC populations as markers for predicting the risk of developing hematogenous metastases and the effectiveness of treatment in patients with tumors of the female reproductive system (breast cancer, endometrial cancer, and ovarian cancer).
The primary objective are:
The secondary objective is to compare the multicolor flow cytometry results with data of ultrasound, CT and/or MRI, serum tumor markers, and immunohistochemical studies in patients with breast cancer, endometrial cancer and ovarian cancer
The overall goal is to study the diagnostic and prognostic efficacy of various CTC populations as liquid biopsy markers in tumors of the female reproductive system (breast cancer, endometrial cancer, and ovarian cancer).
Phase I study:
Determination of different populations of CTCs in blood and ascitic fluid (if any) prior to treatment.
The main objectives of the study:
Additional research tasks:
To compare the multicolor flow cytometry results with the data of ultrasound, CT and/or MRI, serum tumor markers, and immunohistochemical studies in patients with breast cancer, endometrial cancer, and ovarian cancer Methodology: Open-label, exploratory, single centre study. Blood and ascitic fluid collected from subjects (if available)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer | At least eighty five subjects with breast cancer |
| |
| Ovarian cancer | At least 32 subjects with ovarian cancer |
| |
| Endometrial Cancer | At least 33 subjects with endometrial cancer |
| |
| Healthy control | 30 healthy volunteers |
| |
| Suspected malignant tumor non-verified | Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taking 5 ml of venous blood at different time intervals | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| CTC phenotype | Different populations of CTCs are evaluated by multicolor flow cytometry and may include: СTC, ascitic tumor cells with stemness features without EMT features; CTC, ascitic tumor cells without stemness and EMT features; CTC, ascitic tumor cells without stemness features and with EMT features; CTC, ascitic tumor cells with stemness features and EMT features; Atypical/hybrid cells without stemness features; Atypical cells. | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
Active current autoimmune disease or history of autoimmune disease
Gender Based: women for breast cancer, Ovarian cancer, Endometrial Cancer
Women over 18 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Evgeniya Kaigorodova | Tomsk NRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evgeniya Kaigorodova | Tomsk | Tomsk Oblast | 634050 | Russia |
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EDTA-stabilized venous blood (5 mL) EDTA-stabilized ascitic fluid (5 mL)
|
| Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any | Other |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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