Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

NCT04817501 | Completed

• 1 other identifier: CTC Phenotyping
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.To assess the presence and number of different populations of CTCs at different time points (before biopsy, before surgery, and after surgery).
2. 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. 3.To assess the molecular profiles of different CTCs populations in the blood and in ascitic fluid.

Conditions

Breast Cancer; Ovarian Cancer; Endometrial Cancer

Keywords

breast cancer; endometrial Cancer; ovarian cancer; CTC heterogeneity; cancer stem cells; epithelial-mesenchymal transition; multicolor flow cytometry; liquid biopsy; circulating tumor cell

Outcome Measures

Primary Outcomes (1)

• CTC phenotype

  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.

  6 hours

Study Arms (5)

Breast cancer

At least eighty five subjects with breast 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

Ovarian cancer

At least 32 subjects with ovarian 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

Endometrial Cancer

At least 33 subjects with 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

Healthy control

30 healthy volunteers

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

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

Interventions

Taking 5 ml of venous blood at different time intervals OTHER

Also known as: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy

Breast cancer; Endometrial Cancer; Healthy control; Ovarian cancer; Suspected malignant tumor non-verified

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

Breast cancer; Endometrial Cancer; Ovarian cancer; Suspected malignant tumor non-verified

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Gender Based: women for breast cancer, Ovarian cancer, Endometrial Cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years of age.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Evgeniya Kaigorodova

Tomsk, Tomsk Oblast, 634050, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-stabilized venous blood (5 mL) EDTA-stabilized ascitic fluid (5 mL)

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evgeniya Kaigorodova

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: February 14, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 25, 2023

Record last verified: 2022-04

Locations

RU (1)