Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System
Condition: Breast Cancer; Ovarian Cancer; Endometrial Cancer
MeSH terms: Ovarian Neoplasms; Endometrial Neoplasms; Genital Neoplasms, Female
Study type: Observational

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
    

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:

        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)
    

Intervention name(s): Taking 5 ml of venous blood at different time intervals; Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
Intervention type(s): Other; Other
Other intervention name(s): Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy
Intervention MeSH terms: Edetic Acid
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women over 18 years of age.
      
Biospecimen description: 
      EDTA-stabilized venous blood (5 mL) EDTA-stabilized ascitic fluid (5 mL)
    
Keywords: breast cancer; endometrial Cancer; ovarian cancer; CTC heterogeneity; cancer stem cells; epithelial-mesenchymal transition; multicolor flow cytometry; liquid biopsy; circulating tumor cell