Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

Completed

• Conditions: Breast Cancer; Ovarian Cancer; Endometrial Cancer
• Interventions: Other: Taking 5 ml of venous blood at different time intervals; Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any

• Registration Number: NCT04817501
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief 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

Detailed 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)

Study Timeline

• Study Start: 2014-02-14
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Status Verified: 2022-04
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Subject is > 18 years of age A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential.
• Clinical and radiological diagnosis of breast cancer or Ovarian cancer or Endometrial Cancer General satisfactory condition (according to the ECOG scale ≤2) Subject is capable to undergo the diagnostic investigations to be performed in the study
• Informed consent

Exclusion Criteria

• Active current autoimmune disease or history of autoimmune disease

  • Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
  • Known HIV positive or chronically active hepatitis B or C The subject has multiple primary malignant tumors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrial Cancer	Taking 5 ml of venous blood at different time intervals	At least 33 subjects with endometrial cancer
Suspected malignant tumor non-verified	Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any	Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined
Breast cancer	Taking 5 ml of venous blood at different time intervals	At least eighty five subjects with breast cancer
Breast cancer	Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any	At least eighty five subjects with breast cancer
Ovarian cancer	Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any	At least 32 subjects with ovarian cancer
Endometrial Cancer	Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any	At least 33 subjects with endometrial cancer
Healthy control	Taking 5 ml of venous blood at different time intervals	30 healthy volunteers
Ovarian cancer	Taking 5 ml of venous blood at different time intervals	At least 32 subjects with ovarian cancer
Suspected malignant tumor non-verified	Taking 5 ml of venous blood at different time intervals	Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined

Primary Outcome Measures

Name	Time	Method
CTC phenotype	6 hours	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.

Trial Locations

Locations (1)

Evgeniya Kaigorodova; 🇷🇺 Tomsk, Tomskaya Oblast, Russian Federation