Clinical trial · Observational
Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics
A Prospective Study of Early Detection of Endometrial 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 endometrial 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 endometrial cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five different feature types, including Fragment Size Distribution, nucleosome features, SBS Signatures, BreakPoint Motif , and Copy Number Variation 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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-depth whole-genome sequencing technology | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with endometrial cancer
- description
- the 108 patients with early to mid-stage endometrial cancer, more than 50% were in FIGO stages I/II.
- interventionNames
- Genetic: low-depth whole-genome sequencing technology
- label
- healthy people
- description
- 108 healthy people
- interventionNames
- Genetic: low-depth whole-genome sequencing technology
Primary outcomes (1)
- measure
- Area under curve of the model for detecting endometrial cancer
- timeFrame
- 1 year
- description
- The area under curve of the model for the ultrasensitive early detection of endometrial cancer would be evaluate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age minimum 18 years * Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination. * Ability to understand and the willingness to sign a written informed consent document * Participants can obtain comprehensive clinical and pathological information. * 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-endometrial 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