Clinical trial · Observational
Blood-Based Minimal Residual Disease in Advanced Epithelial Ovarian Cancer After 1st Line Therapy
The Role of Blood-Based Minimal Residual Disease in Patients With Advanced Epithelial Ovarian Cancer After 1st Line Therapy
- 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)
The purpose of this observational study is to learn if a specialized blood test can help predict whether advanced ovarian cancer will return after a patient's initial treatments are finished. Researchers are inviting women who have been diagnosed with stage III or IV epithelial ovarian cancer and have recently completed their first-line treatments, which include surgery and platinum-based chemotherapy. The study focuses on "circulating tumor DNA" (ctDNA), which are tiny fragments of genetic material that cancer cells release into the bloodstream as they break down. Finding these DNA fragments in the blood when a patient appears to be cancer-free on standard tests is known as assessing for minimal residual disease (MRD). Because this is an observational study, participants will receive standard medical care as directed by their doctor. For the research portion, participants will provide blood samples at specific times: at the time of diagnosis, shortly after surgery, right after finishing their first-line chemotherapy, and then every 3 months during regular follow-up visits. Researchers will also analyze a sample of the tumor tissue that was already removed during the patient's standard surgery. By tracking these participants for up to 3 years, researchers hope to discover if the ctDNA test can accurately identify patients who have a high risk of their cancer returning, and if it can detect this earlier than traditional imaging scans or standard blood tests like CA-125.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Ovarian Epithelial | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood-based ctDNA minimal residual disease (MRD) test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced Epithelial Ovarian Cancer Cohort
- description
- Patients with FIGO stage III-IV high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer who have completed primary or interval debulking surgery and platinum-based chemotherapy, and show a complete response. This cohort will undergo non-invasive blood-based minimal residual disease (MRD) monitoring using an NGS-based ctDNA assay (AlphaLiquid®100) to evaluate its utility in predicting recurrence.
- interventionNames
- Diagnostic Test: Blood-based ctDNA minimal residual disease (MRD) test
Primary outcomes (1)
- measure
- Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status
- timeFrame
- Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period)
- description
- Relapse-Free Survival (RFS) is defined as the time from the completion of standard first-line therapy to the date of the first documented radiological or clinical disease recurrence, or death from any cause. This measure evaluates the correlation between ctDNA positivity (baseline MRD status, measured within 2-4 weeks after completing 1st-line therapy) and RFS. The median RFS and Hazard Ratio (HR) will be compared between the ctDNA-positive and ctDNA-negative patient groups.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: Women aged 19 years or older. Pathologically confirmed high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer. FIGO stage III or IV. Patients who have completed primary debulking surgery (PDS) or interval debulking surgery (IDS) and platinum-based chemotherapy (subsequent maintenance therapy, such as bevacizumab or PARP inhibitors, is allowed). Patients showing radiological or clinical Complete Response (CR) after the completion of platinum-based chemotherapy. Written informed consent for the study. Exclusion Criteria: Radiological progressive disease during or immediately after treatment. Expected survival of 3 months or less. Immunodeficiency or pathological bleeding tendencies. Unable to undergo blood tests or unwilling to undergo repeated blood sampling. Concurrent other solid tumors or history of malignant tumors within the last 5 years. Refusal to consent to participate in this study.
References
Publications (0)
Data not yet available