Clinical trial · Interventional
ASTRA Study: Circulating Tumor Cells in Blood of Patients With High-Grade Serous Ovarian Cancer
ASTRA: Circulating Tumor Cells in Blood of Patients With High-Grade Serous Ovarian Cancer-Morphology, Immunophenotype, and Association With Clinical Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral Blood Collection for CTC Isolation and Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peripheral Blood Collection for CTC Analysis
- description
- 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.
- interventionNames
- Other: Peripheral Blood Collection for CTC Isolation and Analysis
Primary outcomes (1)
- measure
- Number of Circulating Tumor Cells (CTCs) per 10 mL of Peripheral Blood
- timeFrame
- Baseline (prior to initiation of systemic therapy)
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Presence of another active malignancy. * Any condition that, in the opinion of the investigators, could interfere with study participation or interpretation of results.
References
Publications (0)
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