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Completed
NCT04817501
Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System
Conditions: Breast Cancer, Ovarian Cancer, Endometrial Cancer
Sex: Female
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Enrollment: 150
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Location: Evgeniya Kaigorodova Tomsk Tomsk Oblast
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04817501). StuddyBuddy aggregates publicly available trial information.