Brief Title
Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System
Official Title
Phenotypic Spectrum of Circulating Tumor Cell Populations as Markers of Liquid Biopsy in Tumors of the Female Reproductive System
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. 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)
Study Type
Observational
Primary Outcome
CTC phenotype
Condition
Breast Cancer
Intervention
Taking 5 ml of venous blood at different time intervals
Study Arms / Comparison Groups
Breast cancer
Description: At least eighty five subjects with breast cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
150
Start Date
February 14, 2014
Completion Date
December 1, 2022
Primary Completion Date
December 1, 2022
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
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Evgeniya Kaigorodova, +7-3822-282686, [email protected]
Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT04817501
Organization ID
CTC Phenotyping
Responsible Party
Sponsor
Study Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study Sponsor
Evgeniya Kaigorodova, Principal Investigator, Tomsk NRMC
Verification Date
March 2021