ASTRA Study: Circulating Tumor Cells in Blood of Patients With High-Grade Serous Ovarian Cancer

NCT07439328 | Completed

• 2 other identifiers: OIL_ASTRA_2023ERID-KSOPR-0088/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Ovarian Cancer

Keywords

CTC clusters; high-grade serous ovarian cancer; progression-free survival

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (prior to initiation of systemic therapy)

Secondary Outcomes (3)

• Presence of Circulating Tumor Cell (CTC) Clusters

  Baseline (prior to initiation of systemic therapy)

• Number of Megakaryocytes Detected per 10 mL of Peripheral Blood

  Baseline (prior to initiation of systemic therapy)

• Proportion of Circulating Tumor Cells Expressing Immunophenotypic Markers

  Baseline and pre-cycle 4 assessment (up to 12 weeks)

Study Arms (1)

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.

Other: Peripheral Blood Collection for CTC Isolation and Analysis

Interventions

Peripheral Blood Collection for CTC Isolation and Analysis OTHER

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.

Peripheral Blood Collection for CTC Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of another active malignancy.
• Any condition that, in the opinion of the investigators, could interfere with study participation or interpretation of results.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)