Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System (CTCs)
-
- STATUS
- Recruiting
-
- End date
- Dec 1, 2022
-
- participants needed
- 150
-
- sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
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
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.
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)
Details
| Condition | Breast Cancer, Ovarian Cancer, Endometrial Cancer |
|---|---|
| Treatment | Taking 5 ml of venous blood at different time intervals, Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any |
| Clinical Study Identifier | NCT04817501 |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Last Modified on | 11 May 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer