Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System
NCT ID: NCT04817501
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2014-02-14
2022-12-01
Brief Summary
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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
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Detailed Description
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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)
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Breast cancer
At least eighty five subjects with breast cancer
Taking 5 ml of venous blood at different time intervals
Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
Ovarian cancer
At least 32 subjects with ovarian cancer
Taking 5 ml of venous blood at different time intervals
Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
Endometrial Cancer
At least 33 subjects with endometrial cancer
Taking 5 ml of venous blood at different time intervals
Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
Healthy control
30 healthy volunteers
Taking 5 ml of venous blood at different time intervals
Suspected malignant tumor non-verified
Patients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined
Taking 5 ml of venous blood at different time intervals
Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
Interventions
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Taking 5 ml of venous blood at different time intervals
Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
FEMALE
Yes
Sponsors
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Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Evgeniya Kaigorodova
Role: PRINCIPAL_INVESTIGATOR
Tomsk NRMC
Locations
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Evgeniya Kaigorodova
Tomsk, Tomsk Oblast, Russia
Countries
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Other Identifiers
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CTC Phenotyping
Identifier Type: -
Identifier Source: org_study_id
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