Ovarian CancerNCT07439328
ASTRA Study: Circulating Tumor Cells in Blood of Patients With High-Grade Serous Ovarian Cancer
A study testing Peripheral Blood Collection for CTC Isolation and Analysis in people with Ovarian Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
High-grade serous ovarian cancer is typically diagnosed at an advanced stage and remains associated with poor long-term survival. Reliable biomarkers for predicting disease course and treatment response are still limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Peripheral Blood Collection for CTC Isolation and Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Histologically confirmed high-grade serous ovarian cancer.
- FIGO stage III or IV disease.
- Indication for first-line platinum-based systemic therapy.
- ECOG/WHO performance status 0-2.
- Ability to provide peripheral blood samples.
- Written informed consent obtained prior to participation.
Who cannot join
- Presence of another active malignancy.
- Any condition that, in the opinion of the investigators, could interfere with study participation or interpretation of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASTRA: Circulating Tumor Cells in Blood of Patients With High-Grade Serous Ovarian Cancer-Morphology, Immunophenotype, and Association With Clinical Outcomes
High-grade serous ovarian cancer is typically diagnosed at an advanced stage and remains associated with poor long-term survival. Reliable biomarkers for predicting disease course and treatment response are still limited.
Circulating tumor cells (CTCs) are malignant cells that detach from the primary tumor and enter the bloodstream. Their presence has been associated with disease progression and prognosis in several malignancies, including ovarian cancer. However, data on the morphological characteristics, immunophenotype, and clinical relevance of CTCs in high-grade serous ovarian cancer remain limited.
Read more
The ASTRA study evaluates the number and characteristics of circulating tumor cells in peripheral blood samples obtained from patients with high-grade serous ovarian cancer. The study examines CTC count, presence of CTC clusters and megakaryocytes, and immunophenotypic marker expression, and explores associations between CTC findings and clinical parameters and outcomes.
Results from this study may contribute to improved understanding of circulating tumor cells in ovarian cancer and support the development of liquid biopsy approaches for prognostic assessment and disease monitoring.
Read the detailed description
This prospective, single-arm interventional diagnostic study evaluates circulating tumor cells (CTCs) in patients with high-grade serous ovarian cancer (HGSC). The study is designed to characterize the morphological and immunophenotypic features of CTCs and to assess their association with clinical and prognostic parameters.
Eligible participants include adult women with histologically confirmed high-grade serous ovarian cancer (FIGO stage III or IV) undergoing first-line platinum-based systemic therapy. As part of the study protocol, an additional 10 mL peripheral blood sample is collected prior to initiation of systemic therapy. In participants with detectable CTCs at baseline, a second additional 10 mL blood sample is collected before cycle 4 of systemic therapy to evaluate treatment-related changes in CTC count and characteristics.
Circulating tumor cells are isolated using the Parsortix size-based microfluidic system, which preserves cellular morphology. Isolated cells are processed into cytospin preparations and analyzed using cytology staining, immunocytochemistry, and immunofluorescence methods. CTCs are evaluated for number, presence of single cells and clusters, and expression of epithelial and mesenchymal markers. Megakaryocytes and other non-tumor cells are assessed to ensure accurate cell classification.
Clinical data, including tumor stage, laboratory parameters (e.g., CA125 and immune-inflammatory indices), treatment information, and outcome data, are obtained from medical records. Progression-free survival and overall survival are assessed using clinical follow-up data and the national cancer registry.
Statistical analyses include descriptive statistics, correlation analyses between CTC findings and clinical parameters, and survival analyses using Kaplan-Meier methods and multivariable Cox regression models.
This study provides detailed insight into circulating tumor cells in high-grade serous ovarian cancer and explores their potential role as prognostic biomarkers and tools for future clinical and translational research.
- Conditions
- Ovarian Cancer
- Being tested
- Peripheral Blood Collection for CTC Isolation and Analysis
- Keywords
- CTC clusters, high-grade serous ovarian cancer, progression-free survival
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Blood Collection for CTC Isolation and AnalysisOther
Collection of an additional 10 mL peripheral blood sample for isolation and characterization of circulating tumor cells using the Parsortix size-based microfluidic system, followed by cytological and immunophenotypic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Blood Collection for CTC Analysis | Experimental | Adult women with histologically confirmed high-grade serous ovarian cancer (FIGO stage III or IV) undergoing standard-of-care first-line platinum-based systemic therapy provide an additional 10 mL peripheral blood sample for circulating tumor cell (CTC) isolation and analysis at baseline. In participants with detectable CTCs at baseline, a second additional 10 mL blood sample is collected before cycle 4 of systemic therapy to assess treatment-related changes. Receives: Other: Peripheral Blood Collection for CTC Isolation and Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Circulating Tumor Cells (CTCs) per 10 mL of Peripheral Blood
Total number of circulating tumor cells detected in 10 mL of peripheral blood using the Parsortix size-based isolation system. Results are reported as number of CTCs per participant.
Measured: Baseline (prior to initiation of systemic therapy)
Secondary outcomes (3)
Presence of Circulating Tumor Cell (CTC) Clusters
Presence of circulating tumor cell clusters identified in 10 mL of peripheral blood following isolation and cytological evaluation.
Measured: Baseline (prior to initiation of systemic therapy)
Number of Megakaryocytes Detected per 10 mL of Peripheral Blood
Number of megakaryocytes detected in 10 mL of peripheral blood during cytological evaluation following CTC isolation.
Measured: Baseline (prior to initiation of systemic therapy)
Proportion of Circulating Tumor Cells Expressing Immunophenotypic Markers
Proportion of isolated circulating tumor cells expressing predefined epithelial or mesenchymal markers as assessed by immunocytochemistry and immunofluorescence.
Measured: Baseline and pre-cycle 4 assessment (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439328
- Sponsor's protocol ID
- OIL_ASTRA_2023
- Other IDs
- ERID-KSOPR-0088/2023
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASTRA: Circulating Tumor Cells in Blood of Patients With High-Grade Serous Ovarian Cancer-Morphology, Immunophenotype, and Association With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07439328
- Acronym / sponsor ID
- OIL_ASTRA_2023
- Conditions
- Ovarian Cancer
- Keywords
- CTC clusters, high-grade serous ovarian cancer, progression-free survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Feb 2026 (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.
High-grade serous ovarian cancer is typically diagnosed at an advanced stage and remains associated with poor long-term survival. Reliable biomarkers for predicting disease course and treatment response are still limited.
Circulating tumor cells (CTCs) are malignant cells that detach from the primary tumor and enter the bloodstream. Their presence has been associated with disease progression and prognosis in several malignancies, including ovarian cancer. However, data on the morphological characteristics, immunophenotype, and clinical relevance of CTCs in high-grade serous ovarian cancer remain limited.
The ASTRA study evaluates the number and characteristics of circulating tumor cells in peripheral blood samples obtained from patients with high-grade serous ovarian cancer. The study examines CTC count, presence of CTC clusters and megakaryocytes, and immunophenotypic marker expression, and explores associations between CTC findings and clinical parameters and outcomes.
Results from this study may contribute to improved understanding of circulating tumor cells in ovarian cancer and support the development of liquid biopsy approaches for prognostic assessment and disease monitoring.
Detailed description
This prospective, single-arm interventional diagnostic study evaluates circulating tumor cells (CTCs) in patients with high-grade serous ovarian cancer (HGSC). The study is designed to characterize the morphological and immunophenotypic features of CTCs and to assess their association with clinical and prognostic parameters.
Eligible participants include adult women with histologically confirmed high-grade serous ovarian cancer (FIGO stage III or IV) undergoing first-line platinum-based systemic therapy. As part of the study protocol, an additional 10 mL peripheral blood sample is collected prior to initiation of systemic therapy. In participants with detectable CTCs at baseline, a second additional 10 mL blood sample is collected before cycle 4 of systemic therapy to evaluate treatment-related changes in CTC count and characteristics.
Circulating tumor cells are isolated using the Parsortix size-based microfluidic system, which preserves cellular morphology. Isolated cells are processed into cytospin preparations and analyzed using cytology staining, immunocytochemistry, and immunofluorescence methods. CTCs are evaluated for number, presence of single cells and clusters, and expression of epithelial and mesenchymal markers. Megakaryocytes and other non-tumor cells are assessed to ensure accurate cell classification.
Clinical data, including tumor stage, laboratory parameters (e.g., CA125 and immune-inflammatory indices), treatment information, and outcome data, are obtained from medical records. Progression-free survival and overall survival are assessed using clinical follow-up data and the national cancer registry.
Statistical analyses include descriptive statistics, correlation analyses between CTC findings and clinical parameters, and survival analyses using Kaplan-Meier methods and multivariable Cox regression models.
This study provides detailed insight into circulating tumor cells in high-grade serous ovarian cancer and explores their potential role as prognostic biomarkers and tools for future clinical and translational research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Blood Collection for CTC Analysis | Experimental | Other: Peripheral Blood Collection for CTC Isolation and AnalysisAdult women with histologically confirmed high-grade serous ovarian cancer (FIGO stage III or IV) undergoing standard-of-care first-line platinum-based systemic therapy provide an additional 10 mL peripheral blood sample for circulating tumor cell (CTC) isolation and analysis at baseline. In participants with detectable CTCs at baseline, a second additional 10 mL blood sample is collected before cycle 4 of systemic therapy to assess treatment-related changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged 18 years or older.
Key exclusion criteria (2 listed)
- Presence of another active malignancy.
- Any condition that, in the opinion of the investigators, could interfere with study participation or interpretation of results.
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 |
|---|---|---|
| Peripheral Blood Collection for CTC Isolation and AnalysisCollection of an additional 10 mL peripheral blood sample for isolation and characterization of circulating tumor cells using the Parsortix size-based microfluidic system, followed by cytological and immunophenotypic analysis. | Other | Peripheral Blood Collection for CTC Analysis |
Primary outcome
Number of Circulating Tumor Cells (CTCs) per 10 mL of Peripheral Blood
Time frame: Baseline (prior to initiation of systemic therapy)
Total number of circulating tumor cells detected in 10 mL of peripheral blood using the Parsortix size-based isolation system. Results are reported as number of CTCs per participant.
3 secondary outcomes
Presence of Circulating Tumor Cell (CTC) Clusters
Time frame: Baseline (prior to initiation of systemic therapy)
Number of Megakaryocytes Detected per 10 mL of Peripheral Blood
Time frame: Baseline (prior to initiation of systemic therapy)
Proportion of Circulating Tumor Cells Expressing Immunophenotypic Markers
Time frame: Baseline and pre-cycle 4 assessment (up to 12 weeks)
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Blood Collection for CTC Isolation and Analysis in people with Ovarian Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 7 inclusion and 2 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 27 Feb 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 Slovenia. 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?
Number of Circulating Tumor Cells (CTCs) per 10 mL of Peripheral Blood (time frame: Baseline (prior to initiation of systemic therapy)). 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 27 Feb 2026.