Clinical trial · Observational
Early Detection of Ovarian Cancer Using Plasma Cell-free DNA Fragmentomics (Prospective Study)
A Prospective Study of Early Detection of Ovarian Cancer Using Plasma Cell-free DNA Fragmentomics
- 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 study is to enable non-invasive early detection of ovarian cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage ovarian cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five diferent feature types, including Fragment Size Coverage (FSC), Fragment Size Distribution (FSD), EnD Motif (EDM), BreakPoint Motif (BPM), and Copy Number Variation (CNV) will be assessed to generate this model.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- stage I-II ovarian cancer
- description
- 54 patients with stage I-II ovarian cancer
- label
- stage III-IV ovarian cancer
- description
- 54 patients with stage III-IV ovarian cancer
- label
- benign ovarian cancer
- description
- 40 patients with benign ovarian cancer
- label
- healthy people
- description
- 100 healthy people
Primary outcomes (1)
- measure
- Area under curve of the model for detecting ovarian cancer
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age minimum 18 years * Patients with I-IV ovarian cancer or benign tumor confirmed by pathological examination. * Ability to understand and the willingness to sign a written informed consent document * Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening Exclusion Criteria: * Participants must not be pregnant or breastfeeding * Participants must not have prior cancer histories or a second non-ovarian malignancy * Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy * Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection * Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation * Participants with clinically important abnormalities or conditions unsuitable for blood collection * Any other disease or clinical condition of participants that the researcher believes may affect the compliance of the protocol, or affect the patient's signing of the informed consent form (ICF), which is not suitable to participate in this clinical trial.
References
Publications (0)
Data not yet available