Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

Breast Cancer Clinical Trial

— CTCs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817501
• Other study ID #: CTC Phenotyping
• Status: Completed
• Start date: February 14, 2014
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2022
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
Russian Federation	Evgeniya Kaigorodova	Tomsk	Tomskaya Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTC phenotype	Different populations of CTCs are evaluated by multicolor flow cytometry and may include: ?TC, 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.	6 hours