Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplastic Cells, Circulating

Endometrial Neoplasms

Genital Neoplasms, Female

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Anticoagulants

All Drugs and Chemicals

Bone Density Conservation Agents

Edetic Acid

Pentetic Acid

Calcium

Calcium, Dietary

Chelating Agents

At least eighty five subjects with breast cancer

At least 33 subjects with endometrial cancer

Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined

Taking 5 ml of venous blood at different time intervals

Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any

Evgeniya Kaigorodova

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:

1. To assess the presence and number of different populations of CTCs at different time points (before biopsy, before surgery, and after surgery).
2. To assess the relationships of different CTCs populations prior to treatment initiation with the effects of neoadjuvant chemotherapy and the risks of recurrence and metastases.
3. To assess the molecular profiles of different CTCs populations in the blood and in ascitic fluid.

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:

1. To assess the presence and number of different CTC populations at different time points (before biopsy and before surgery) using multicolor flow cytometry.
2. To assess the relationships between different CTCs populations prior to treatment initiation with the effects of neoadjuvant chemotherapy and the risks of recurrence and metastases.
3. To assess the molecular profiles of different CTCs populations in the blood and in ascitic fluid.

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)

EDTA-stabilized venous blood (5 mL) EDTA-stabilized ascitic fluid (5 mL)

Gender Based: women for breast cancer, Ovarian cancer, Endometrial Cancer

Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

Phenotypic Spectrum of Circulating Tumor Cell Populations as Markers of Liquid Biopsy in Tumors of the Female Reproductive System

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.

Tomsk National Research Medical Center of the Russian Academy of Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System	NCT04817501	Breast Cancer Ovarian Cancer Endometrial Can...	Taking 5 ml of ... Taking 5 ml EDT...	18 Years - 80 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences
Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System	NCT04817501	Breast Cancer Ovarian Cancer Endometrial Can...	Taking 5 ml of ... Taking 5 ml EDT...	18 Years - 80 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences

Spots Global Cancer Trial Database for taking 5 ml of venous blood at different time intervals