Phenotypic Spectrum of Circulating Tumor Cell Populations as Markers of Liquid Biopsy in Tumors of the Female Reproductive System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- CTC phenotype
Study Overview
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Breast cancer
At least eighty five subjects with breast cancer
Intervention: Taking 5 ml of venous blood at different time intervals (Other)
Breast cancer
At least eighty five subjects with breast cancer
Intervention: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any (Other)
Ovarian cancer
At least 32 subjects with ovarian cancer
Intervention: Taking 5 ml of venous blood at different time intervals (Other)
Ovarian cancer
At least 32 subjects with ovarian cancer
Intervention: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any (Other)
Endometrial Cancer
At least 33 subjects with endometrial cancer
Intervention: Taking 5 ml of venous blood at different time intervals (Other)
Endometrial Cancer
At least 33 subjects with endometrial cancer
Intervention: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any (Other)
Healthy control
30 healthy volunteers
Intervention: Taking 5 ml of venous blood at different time intervals (Other)
Suspected malignant tumor non-verified
Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined
Intervention: Taking 5 ml of venous blood at different time intervals (Other)
Suspected malignant tumor non-verified
Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined
Intervention: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any (Other)
Outcomes
Primary Outcomes
CTC phenotype
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported