Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04817501

Collaborator

(none)

150

Enrollment

Location

105.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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:

To assess the presence and number of different populations of CTCs at different time points (before biopsy, before surgery, and after surgery).
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.
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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Ovarian Cancer Endometrial Cancer	Other: Taking 5 ml of venous blood at different time intervals Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any

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:

To assess the presence and number of different CTC populations at different time points (before biopsy and before surgery) using multicolor flow cytometry.
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.
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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 14, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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