Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Endometrial Cancer; Breast Cancer; Ovarian Cancer

Treatments: Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any; Other: Taking 5 ml of venous blood at different time intervals

Study type: Observational

Funder types: Other

Identifiers

NCT04817501

CTC Phenotyping

Details and patient eligibility

About

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

Full 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)

Enrollment: 150 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 5 patient groups

Breast cancer

Description:

At least eighty five subjects with breast cancer

Treatment:

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

Other: Taking 5 ml of venous blood at different time intervals

Ovarian cancer

Description:

At least 32 subjects with ovarian cancer

Treatment:

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

Other: Taking 5 ml of venous blood at different time intervals

Endometrial Cancer

Description:

At least 33 subjects with endometrial cancer

Treatment:

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

Other: Taking 5 ml of venous blood at different time intervals

Healthy control

Description:

30 healthy volunteers

Treatment:

Other: Taking 5 ml of venous blood at different time intervals

Suspected malignant tumor non-verified

Description:

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

Treatment:

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

Other: Taking 5 ml of venous blood at different time intervals