cfHPV DNA in Plasma of Cervical Cancer PatientsNCT06420427
Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery
An observational study of cfHPV DNA in Plasma of Cervical Cancer Patients, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- cfHPV DNA in Plasma of Cervical Cancer Patients
- What is being tested?
- Assess the risk of recurrence and the efficacy of medication
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
Who may be able to join
- Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
- Patients must be older than 18 years of age.
- Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
- Estimated life expectancy of more than three months.
- Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
- Able to provide specimens and corresponding clinical information at each time point.
Who cannot join
- Patients who are participating in other clinical trials.
- Pregnant or breastfeeding women.
- Patients with severe mental illness.
- Patients who voluntarily withdraw.
- Patients unable to complete the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
Baixue Li, MD, 86-02-81292726, 19902275248@163.com
About this study
Official title: Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.
- Being tested
- Assess the risk of recurrence and the efficacy of medication
- Keywords
- cfHPV DNA, cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the risk of recurrence and the efficacy of medicationDiagnostic test
Evaluation of recurrence risk and medication efficacy through liquid biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
true positive rate
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cfHPV DNA in Plasma of Cervical Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Xiujie, The Third Affiliated Hospital of Guangzhou Medical University
- Investigators
- Xiujie Sheng, Prof, Study chair, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420427
- Sponsor's protocol ID
- CCA2024005
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publish an article
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
- ClinicalTrials.gov ID
- NCT06420427
- Acronym / sponsor ID
- CCA2024005
- Keywords
- cfHPV DNA, cervical cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
Key inclusion criteria (6 listed)
- Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
- Patients must be older than 18 years of age.
- Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
- Estimated life expectancy of more than three months.
- Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
Key exclusion criteria (5 listed)
- Patients who are participating in other clinical trials.
- Pregnant or breastfeeding women.
- Patients with severe mental illness.
- Patients who voluntarily withdraw.
- Patients unable to complete the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assess the risk of recurrence and the efficacy of medicationEvaluation of recurrence risk and medication efficacy through liquid biopsy | Diagnostic test | – |
Primary outcome
sensitivity
Time frame: 2 year
true positive rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No. publish an article
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiujie Sheng, Prof study chair
The Third Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of cfHPV DNA in Plasma of Cervical Cancer Patients, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiujie Sheng, Prof (86-20-81292726, 2008691150@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.