Feasibility Study of Blood Biomarker Identification in Cervical Cancer

NCT07796672 | Recruiting

• 1 other identifier: CLARITY
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Adenocarcinoma; Cervical Squamous Cell Carcinoma

Keywords

Cervical Cancer; blood biomarker; cell-free DNA; extracellular vesicles

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with successful blood collection and analysable cfDNA and EVs

  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.

  Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.

Secondary Outcomes (9)

• Proportion of eligible patients who consent to participate

  At study screening/enrolment.

• Proportion of cfDNA samples meeting prespecified analytical quality criteria

  Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.

• Proportion of extracellular vesicle samples meeting prespecified analytical quality criteria

  Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.

• Association between baseline cfDNA profiles and cervical cancer stage

  Baseline

• Association between baseline extracellular vesicle profiles and cervical cancer stage

  Baseline

Study Arms (1)

Patients with Cervical Cancer

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.

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

Interventions

Blood Sample Collection PROCEDURE

Approximately 40 mL of blood will be collected at baseline, approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy, and 6 months (±14 days) post-baseline. Blood samples will be processed for isolation and analysis of cell-free DNA (cfDNA), extracellular vesicles (EVs), and germline DNA.

Also known as: Peripheral blood collection, Biospecimen collection

Patients with Cervical Cancer

cfDNA and Extracellular Vesicle Biomarker Analysis OTHER

Blood-derived cell-free DNA (cfDNA) and extracellular vesicles (EVs) will be isolated and characterised using prespecified laboratory methods. cfDNA will be quantified, quality assessed, and may undergo sequencing. EVs will be characterised using methods including nanoparticle tracking analysis, transmission electron microscopy, western blotting, proteomics, and miRNA sequencing. Biomarker profiles will be evaluated in relation to disease stage, treatment response, and disease outcomes.

Patients with Cervical Cancer

Patient-Reported Outcome and Quality-of-Life Assessment OTHER

Participants will complete patient-reported outcome and quality-of-life questionnaires at baseline, approximately 8 weeks after surgery or completion of radiotherapy/chemoradiotherapy, and 6 months post-baseline. Assessments include the FACT-Cx, EQ-5D-5L, and self-reported lower-extremity lymphoedema questionnaires.

Patients with Cervical Cancer

Tumour Tissue Biomarker Analysis OTHER

Formalin-fixed paraffin-embedded (FFPE) tumour tissue obtained during routine diagnostic biopsy or surgery will be retrieved from pathology laboratories where available. No research-specific tumour biopsy or surgery will be performed. Tumour tissue may undergo DNA extraction and sequencing for comparison with blood-derived DNA and other prespecified translational analyses.

Patients with Cervical Cancer

Eligibility Criteria

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

Study Population

100 patients with histologically confirmed squamous cell carcinoma or adenocarcinoma of the cervix (stage 1a to 4b).

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead

Study Sites (1)

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and cervical tumor tissue collected from participants with cervical cancer for biomarker/translational research

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cell-Free Nucleic Acids; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Andreas Obermair

CONTACT

+61 7 3346 5073; a.obermair@uq.edu.au

Sara Baniahmadi

CONTACT

+61 7 3346 5073; s.baniahmadi@uq.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 15, 2030
• Study Completion (Estimated): September 15, 2032
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)