Breast CancerCTCsNCT04817501
Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System
An observational study of Breast Cancer and Ovarian Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Endometrial Cancer
- What is being tested?
- Taking 5 ml of venous blood at different time intervals and Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 14 Feb 2014to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women over 18 years of age.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotypic Spectrum of Circulating Tumor Cell Populations as Markers of Liquid Biopsy in Tumors of the Female Reproductive System
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:
Read more
- 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
Read the 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:
- 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)
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer
- Being tested
- Taking 5 ml of venous blood at different time intervals, Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any
- Keywords
- breast cancer, endometrial Cancer, ovarian cancer, CTC heterogeneity, cancer stem cells, epithelial-mesenchymal transition, multicolor flow cytometry, liquid biopsy, circulating tumor cell
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking 5 ml of venous blood at different time intervalsOther
Also called Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy
Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if anyOther
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | At least eighty five subjects with breast cancer Receives: Other: Taking 5 ml of venous blood at different time intervals; Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any | |
| Ovarian cancer | At least 32 subjects with ovarian cancer Receives: Other: Taking 5 ml of venous blood at different time intervals; Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any | |
| Endometrial Cancer | At least 33 subjects with endometrial cancer Receives: Other: Taking 5 ml of venous blood at different time intervals; Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any | |
| Healthy control | 30 healthy volunteers Receives: Other: 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 Receives: Other: Taking 5 ml of venous blood at different time intervals; Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC phenotype
Different populations of CTCs are evaluated by multicolor flow cytometry and may include:
СTC, ascitic tumor cells with stemness features without EMT features; CTC, ascitic tumor cells without stemness and EMT features; CTC, ascitic tumor cells without stemness features and with EMT features; CTC, ascitic tumor cells with stemness features and EMT features; Atypical/hybrid cells without stemness features; Atypical cells.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start14 Feb 2014
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evgeniya Kaigorodova, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817501
- Sponsor's protocol ID
- ORI-3E
- Acronym
- CTCs
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Spectrum of Circulating Tumor Cell Populations as Markers of Liquid Biopsy in Tumors of the Female Reproductive System
- ClinicalTrials.gov ID
- NCT04817501
- Acronym / sponsor ID
- CTCs / ORI-3E
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer
- Keywords
- breast cancer, endometrial Cancer, ovarian cancer, CTC heterogeneity, cancer stem cells, epithelial-mesenchymal transition, multicolor flow cytometry, liquid biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 14 Feb 2014 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Other: Taking 5 ml of venous blood at different time intervals, Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if anyAt least eighty five subjects with breast cancer |
| Ovarian cancer | – | Other: Taking 5 ml of venous blood at different time intervals, Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if anyAt least 32 subjects with ovarian cancer |
| Endometrial Cancer | – | Other: Taking 5 ml of venous blood at different time intervals, Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if anyAt least 33 subjects with endometrial cancer |
| Healthy control | – | Other: Taking 5 ml of venous blood at different time intervals30 healthy volunteers |
| Suspected malignant tumor non-verified | – | Other: Taking 5 ml of venous blood at different time intervals, Other: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if anyPatients with suspected malignant tumor, which was not verified by biopsy. Nubmber of patients to be defined |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years of age.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Active current autoimmune disease or history of autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking 5 ml of venous blood at different time intervalsAlso: Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy | Other | Breast cancer, Endometrial Cancer, Healthy control, Ovarian cancer, Suspected malignant tumor non-verified |
| Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any | Other | Breast cancer, Endometrial Cancer, Ovarian cancer, Suspected malignant tumor non-verified |
Primary outcome
CTC phenotype
Time frame: 6 hours
Different populations of CTCs are evaluated by multicolor flow cytometry and may include: СTC, ascitic tumor cells with stemness features without EMT features; CTC, ascitic tumor cells without stemness and EMT features; CTC, ascitic tumor cells without stemness features and with EMT features; CTC, ascitic tumor cells with stemness features and EMT features; Atypical/hybrid cells without stemness features; Atypical cells.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeniya Kaigorodova principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ovarian Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTC phenotype (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.