Clinical trial · Observational
Feasibility Study of Blood Biomarker Identification in Cervical Cancer
Feasibility Study of Blood Biomarker Identification in Cervical Cancer: Performance of Cell-free DNA Versus Extracellular Vesicles
- 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)
This study aims to explore whether a simple blood test can be used to help detect and monitor cervical cancer. The investigators are studying tiny fragments and particles found in blood, called cell-free DNA (cfDNA) and extracellular vesicles (EVs), to determine whether these can act as early warning signs (biomarkers) of cervical cancer. Cell-free DNA (cfDNA) refers to tiny fragments of genetic material (DNA) that are naturally released from cells into the bloodstream when cells die or renew. Cell-free DNA circulates naturally in the blood. In people with cancer, some of the cfDNA originates from cancer cells; this component is called circulating tumour DNA (ctDNA). Analysis of cfDNA can detect signs of cancer, such as specific genetic changes or pieces of viral DNA, including human papillomavirus (HPV) DNA, without requiring removal of tissue from the cervix. Extracellular vesicles (EVs) are very small "packages" released by cells into the blood and other body fluids. EVs carry messages between cells and contain important information such as proteins, fats, and genetic material, including RNA. In cancer, tumour cells release EVs that reflect tumour behaviour and activity. Analysis of EVs can provide information about cancer growth and response to treatment. Together, cfDNA and EVs can act as tiny messengers or "fingerprints" of biological processes occurring inside the body. Analysis of cfDNA and EVs in blood samples may support the development of a simple, less invasive, more comfortable, and more accessible approach to detecting and monitoring cervical cancer compared with current screening and diagnostic methods. A blood test could also assist doctors in monitoring treatment response or detecting early signs of recurrence without requiring a surgical biopsy. The expected outcomes of this study are to identify specific patterns or "signatures" in extracellular vesicles (EVs) and cell-free DNA (cfDNA) found in blood samples. These signatures could help to: Detect cervical cancer earlier, before symptoms appear or the disease progresses. Monitor treatment response in real time without the need for invasive tests. Predict whether cervical cancer might recur or spread after treatment. Support more personalised care by helping doctors select the most suitable treatment for each participant.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Procedure | — | UNRESOLVED |
| cfDNA and Extracellular Vesicle Biomarker Analysis | Other | — | UNRESOLVED |
| Patient-Reported Outcome and Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Tumour Tissue Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Cervical Cancer
- description
- Patients with FIGO stage IA-IVB cervical cancer undergoing standard-of-care primary surgery, radiotherapy, or chemoradiotherapy. Treatment is determined by the participant's treating clinical team and is not assigned by the study protocol. Participants will undergo serial blood collection for cfDNA and extracellular vesicle analyses, complete patient-reported outcome and quality-of-life questionnaires, and have disease status assessed through medical record review. Archival tumour tissue obtained during routine diagnostic biopsy or surgery will also be retrieved where available for translational analyses.
- interventionNames
- Procedure: Blood Sample Collection
- Other: cfDNA and Extracellular Vesicle Biomarker Analysis
- Other: Patient-Reported Outcome and Quality-of-Life Assessment
- Other: Tumour Tissue Biomarker Analysis
Primary outcomes (1)
- measure
- Proportion of participants with successful blood collection and analysable cfDNA and EVs
- timeFrame
- Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.
- description
- Percentage of enrolled participants for whom blood is successfully collected and both cell-free DNA (cfDNA) and extracellular vesicles (EVs) are successfully isolated and meet prespecified laboratory quality-control criteria for the planned downstream analyses. Feasibility will be assessed at each of the three scheduled blood-collection time points.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females, over 18 years, with histologically confirmed squamous cell carcinoma or adenocarcinoma of the cervix (stage 1a to 4b) * Undergo intensive primary surgical treatment, radiotherapy (RT) or chemoradiotherapy (CRT). * Signed written informed consent Exclusion Criteria: * Unable to provide informed consent * Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ.
References
Publications (0)
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