Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System — CTCs  

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Breast Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Genital Neoplasms, Female
• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT04817501
• Study type: Observational
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Status: Completed
• Start date: February 14, 2014
• Completion date: December 1, 2022