Cervical CancerNCT07782697
Postoperative ctHPV-DNA for Recurrence Prediction and Adjuvant Treatment Decision-Making in Cervical Cancer
An observational study of Cervical Cancer and HPV DNA, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This prospective observational study will evaluate whether changes in circulating tumor human papillomavirus DNA (ctHPV-DNA) after radical surgery can help predict the risk of recurrence in patients with HPV-associated cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, HPV DNA
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2031
- 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 HPV-associated cervical cancer undergoing radical surgical treatment at Anhui Provincial Hospital will be prospectively recruited. Eligible participants will have a trackable tumor-associated HPV genotype identified in tumor tissue or plasma and will undergo serial ctHPV-DNA assessment before surgery and at predefined postoperative time points. Participants will receive postoperative adjuvant treatment or observation according to standard clinical guidelines, pathological risk factors, and multidisciplinary clinical assessment. Treatment allocation will not be determined by this observational study.
Who may be able to join
- Age ≥18 years.
- Histologically confirmed cervical cancer, including squamous cell carcinoma, HPV-associated adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IB1-II cervical cancer undergoing radical surgical treatment; selected patients with postoperative pelvic lymph node metastasis may also be included.
- Undergoing radical hysterectomy with pelvic lymph node dissection, with or without para-aortic lymph node dissection, including sentinel lymph node assessment when applicable.
- A high-risk or intermediate-risk HPV genotype detectable in baseline tumor tissue or plasma, allowing establishment of a trackable ctHPV-DNA target.
- Ability and willingness to undergo serial blood collection and clinical follow-up according to the study protocol.
- Written informed consent.
- For patients who received neoadjuvant chemotherapy, pretreatment ctHPV-DNA information must be available and a trackable HPV target must remain identifiable before surgery or during the early postoperative period.
Who cannot join
- HPV-independent cervical cancer, including gastric-type adenocarcinoma or confirmed HPV-negative squamous cell carcinoma.
- Pelvic radiotherapy administered before radical surgery.
- No residual cervical tumor after conization and inability to establish a reliable baseline HPV target for ctHPV-DNA monitoring.
- Concurrent active HPV-associated malignancy other than cervical cancer.
- Inability to comply with the scheduled blood collection or follow-up procedures.
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
Anhui province hospital
Hefei
Yi Liu, +8615755149324, liuyi0428@mail.ustc.edu.cn
About this study
Official title: Dynamic ctHPV-DNA Monitoring After Radical Surgery for Cervical Cancer to Predict Recurrence Risk and Guide Adjuvant Treatment Decisions: An Exploratory Clinical Study
This prospective observational study will evaluate whether changes in circulating tumor human papillomavirus DNA (ctHPV-DNA) after radical surgery can help predict the risk of recurrence in patients with HPV-associated cervical cancer.
Blood samples will be collected before surgery and at two predefined postoperative time points. The first postoperative assessment (TP#1) will be performed 2-4 weeks after surgery and, for patients scheduled to receive adjuvant therapy, before the start of adjuvant treatment. The second assessment (TP#2) will be performed 12-16 weeks after surgery or, for patients receiving adjuvant therapy, 12-16 weeks after completion of adjuvant treatment.
Read more
Among patients who are ctHPV-DNA negative at TP#1, the study will compare those who remain negative at TP#2 with those who become ctHPV-DNA positive. The primary objective is to determine whether postoperative ctHPV-DNA dynamics are associated with disease-free survival and whether ctHPV-DNA provides additional prognostic information beyond conventional pathological risk factors.
Adjuvant treatment will not be assigned by the study and will be determined according to standard clinical guidelines, pathological risk factors, and multidisciplinary clinical assessment. The study will also explore whether ctHPV-DNA may help identify patients who could benefit from treatment escalation or, conversely, patients at sufficiently low risk who may be candidates for future treatment de-escalation strategies.
Read the detailed description
This is a prospective, single-center, observational cohort study designed to evaluate the prognostic value of serial circulating tumor human papillomavirus DNA (ctHPV-DNA) monitoring after radical surgery for HPV-associated cervical cancer and to explore its potential role in postoperative adjuvant treatment decision-making.
Eligible patients will have histologically confirmed HPV-associated cervical cancer and will undergo radical hysterectomy with pelvic lymph node assessment, with or without para-aortic lymph node assessment as clinically indicated. Adjuvant treatment will not be assigned by the study. Decisions regarding postoperative radiotherapy, chemoradiotherapy, systemic therapy, or observation will be made according to current clinical guidelines, postoperative pathological risk factors, and multidisciplinary clinical assessment.
Peripheral blood will be collected at three predefined time points: before surgery; TP#1, 2-4 weeks after surgery and before initiation of adjuvant therapy when adjuvant treatment is planned; and TP#2, 12-16 weeks after surgery for patients not receiving adjuvant therapy or 12-16 weeks after completion of adjuvant therapy for patients receiving postoperative treatment. ctHPV-DNA will be assessed using a tumor-informed HPV-specific detection approach based on droplet digital polymerase chain reaction (ddPCR) or next-generation sequencing (NGS), depending on HPV genotype and platform applicability. Both qualitative detection status and quantitative ctHPV-DNA levels will be recorded.
The primary analysis will focus on patients who are ctHPV-DNA negative at TP#1 and who are alive and free of radiologically evident recurrence at TP#2. According to ctHPV-DNA status at TP#2, these patients will be classified into two major dynamic groups: persistently negative (negative at TP#1 and negative at TP#2) and molecular conversion to positive (negative at TP#1 and positive at TP#2). Patients who are ctHPV-DNA positive at TP#1 will be followed as a separate high-risk molecular residual disease cohort and analyzed descriptively.
The primary outcome is disease-free survival (DFS), assessed from the TP#2 landmark date to the first occurrence of radiologically or pathologically confirmed recurrence, death, or last follow-up. Secondary outcomes include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, the interval between ctHPV-DNA conversion to positivity and clinically or radiologically detected recurrence, the association between quantitative ctHPV-DNA levels and DFS, and ctHPV-DNA clearance after adjuvant treatment.
The study will further assess whether postoperative ctHPV-DNA dynamics provide incremental prognostic information beyond established clinicopathological risk factors, including Sedlis- and Peters-based risk stratification. Exploratory analyses will compare outcomes according to receipt of adjuvant therapy within ctHPV-DNA-defined subgroups. Because treatment is not randomized, these analyses will be considered hypothesis-generating, and multivariable regression and propensity score-based methods may be used to reduce confounding.
The overall aim is to determine whether serial postoperative ctHPV-DNA monitoring can improve recurrence-risk stratification after radical surgery for cervical cancer and provide prospective evidence to support future interventional trials of ctHPV-DNA-guided escalation or de-escalation of adjuvant therapy.
- Conditions
- Cervical Cancer, HPV DNA
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HPV-Associated Cervical Cancer Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) According to Postoperative ctHPV-DNA Dynamic Status
Disease-free survival (DFS) is defined as the time from the TP#2 ctHPV-DNA assessment to the first occurrence of radiologically or pathologically confirmed cervical cancer recurrence, death from any cause, or last follow-up. The primary analysis will compare DFS between patients who remain ctHPV-DNA negative from TP#1 to TP#2 and those who convert from ctHPV-DNA negative at TP#1 to positive at TP#2.
Measured: From TP#2 to recurrence, death, or last follow-up, up to 2 years
Secondary outcomes (4)
Overall Survival (OS)
Overall survival is defined as the time from the TP#2 ctHPV-DNA assessment to death from any cause or last follow-up.
Measured: From TP#2 to death or last follow-up, up to 2 years
Locoregional Recurrence-Free Survival
Time from the TP#2 ctHPV-DNA assessment to the first radiologically or pathologically confirmed locoregional recurrence, death, or last follow-up.
Measured: From TP#2 to locoregional recurrence, death, or last follow-up, up to 2 years
Distant Metastasis-Free Survival
Time from the TP#2 ctHPV-DNA assessment to the first radiologically or pathologically confirmed distant metastasis, death, or last follow-up.
Measured: From TP#2 to distant metastasis, death, or last follow-up, up to 2 years
Lead Time of Molecular Recurrence Detected by ctHPV-DNA
The interval between the first postoperative conversion of ctHPV-DNA from negative to positive and subsequent radiologically or pathologically confirmed cervical cancer recurrence.
Measured: Time Frame:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782697
- Sponsor's protocol ID
- ZhouYing-ctHPV
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic ctHPV-DNA Monitoring After Radical Surgery for Cervical Cancer to Predict Recurrence Risk and Guide Adjuvant Treatment Decisions: An Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07782697
- Acronym / sponsor ID
- ZhouYing-ctHPV
- Conditions
- Cervical Cancer, HPV DNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 24 Aug 2026 (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.
This prospective observational study will evaluate whether changes in circulating tumor human papillomavirus DNA (ctHPV-DNA) after radical surgery can help predict the risk of recurrence in patients with HPV-associated cervical cancer.
Blood samples will be collected before surgery and at two predefined postoperative time points. The first postoperative assessment (TP#1) will be performed 2-4 weeks after surgery and, for patients scheduled to receive adjuvant therapy, before the start of adjuvant treatment. The second assessment (TP#2) will be performed 12-16 weeks after surgery or, for patients receiving adjuvant therapy, 12-16 weeks after completion of adjuvant treatment.
Among patients who are ctHPV-DNA negative at TP#1, the study will compare those who remain negative at TP#2 with those who become ctHPV-DNA positive. The primary objective is to determine whether postoperative ctHPV-DNA dynamics are associated with disease-free survival and whether ctHPV-DNA provides additional prognostic information beyond conventional pathological risk factors.
Adjuvant treatment will not be assigned by the study and will be determined according to standard clinical guidelines, pathological risk factors, and multidisciplinary clinical assessment. The study will also explore whether ctHPV-DNA may help identify patients who could benefit from treatment escalation or, conversely, patients at sufficiently low risk who may be candidates for future treatment de-escalation strategies.
Detailed description
This is a prospective, single-center, observational cohort study designed to evaluate the prognostic value of serial circulating tumor human papillomavirus DNA (ctHPV-DNA) monitoring after radical surgery for HPV-associated cervical cancer and to explore its potential role in postoperative adjuvant treatment decision-making.
Eligible patients will have histologically confirmed HPV-associated cervical cancer and will undergo radical hysterectomy with pelvic lymph node assessment, with or without para-aortic lymph node assessment as clinically indicated. Adjuvant treatment will not be assigned by the study. Decisions regarding postoperative radiotherapy, chemoradiotherapy, systemic therapy, or observation will be made according to current clinical guidelines, postoperative pathological risk factors, and multidisciplinary clinical assessment.
Peripheral blood will be collected at three predefined time points: before surgery; TP#1, 2-4 weeks after surgery and before initiation of adjuvant therapy when adjuvant treatment is planned; and TP#2, 12-16 weeks after surgery for patients not receiving adjuvant therapy or 12-16 weeks after completion of adjuvant therapy for patients receiving postoperative treatment. ctHPV-DNA will be assessed using a tumor-informed HPV-specific detection approach based on droplet digital polymerase chain reaction (ddPCR) or next-generation sequencing (NGS), depending on HPV genotype and platform applicability. Both qualitative detection status and quantitative ctHPV-DNA levels will be recorded.
The primary analysis will focus on patients who are ctHPV-DNA negative at TP#1 and who are alive and free of radiologically evident recurrence at TP#2. According to ctHPV-DNA status at TP#2, these patients will be classified into two major dynamic groups: persistently negative (negative at TP#1 and negative at TP#2) and molecular conversion to positive (negative at TP#1 and positive at TP#2). Patients who are ctHPV-DNA positive at TP#1 will be followed as a separate high-risk molecular residual disease cohort and analyzed descriptively.
The primary outcome is disease-free survival (DFS), assessed from the TP#2 landmark date to the first occurrence of radiologically or pathologically confirmed recurrence, death, or last follow-up. Secondary outcomes include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, the interval between ctHPV-DNA conversion to positivity and clinically or radiologically detected recurrence, the association between quantitative ctHPV-DNA levels and DFS, and ctHPV-DNA clearance after adjuvant treatment.
The study will further assess whether postoperative ctHPV-DNA dynamics provide incremental prognostic information beyond established clinicopathological risk factors, including Sedlis- and Peters-based risk stratification. Exploratory analyses will compare outcomes according to receipt of adjuvant therapy within ctHPV-DNA-defined subgroups. Because treatment is not randomized, these analyses will be considered hypothesis-generating, and multivariable regression and propensity score-based methods may be used to reduce confounding.
The overall aim is to determine whether serial postoperative ctHPV-DNA monitoring can improve recurrence-risk stratification after radical surgery for cervical cancer and provide prospective evidence to support future interventional trials of ctHPV-DNA-guided escalation or de-escalation of adjuvant therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV-Associated Cervical Cancer Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HPV-associated cervical cancer undergoing radical surgical treatment at Anhui Provincial Hospital will be prospectively recruited. Eligible participants will have a trackable tumor-associated HPV genotype identified in tumor tissue or plasma and will undergo serial ctHPV-DNA assessment before surgery and at predefined postoperative time points. Participants will receive postoperative adjuvant treatment or observation according to standard clinical guidelines, pathological risk factors, and multidisciplinary clinical assessment. Treatment allocation will not be determined by this observational study.
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Histologically confirmed cervical cancer, including squamous cell carcinoma, HPV-associated adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IB1-II cervical cancer undergoing radical surgical treatment; selected patients with postoperative pelvic lymph node metastasis may also be included.
- Undergoing radical hysterectomy with pelvic lymph node dissection, with or without para-aortic lymph node dissection, including sentinel lymph node assessment when applicable.
- A high-risk or intermediate-risk HPV genotype detectable in baseline tumor tissue or plasma, allowing establishment of a trackable ctHPV-DNA target.
Key exclusion criteria (5 listed)
- HPV-independent cervical cancer, including gastric-type adenocarcinoma or confirmed HPV-negative squamous cell carcinoma.
- Pelvic radiotherapy administered before radical surgery.
- No residual cervical tumor after conization and inability to establish a reliable baseline HPV target for ctHPV-DNA monitoring.
- Concurrent active HPV-associated malignancy other than cervical cancer.
- Inability to comply with the scheduled blood collection or follow-up procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-Free Survival (DFS) According to Postoperative ctHPV-DNA Dynamic Status
Time frame: From TP#2 to recurrence, death, or last follow-up, up to 2 years
Disease-free survival (DFS) is defined as the time from the TP#2 ctHPV-DNA assessment to the first occurrence of radiologically or pathologically confirmed cervical cancer recurrence, death from any cause, or last follow-up. The primary analysis will compare DFS between patients who remain ctHPV-DNA negative from TP#1 to TP#2 and those who convert from ctHPV-DNA negative at TP#1 to positive at TP#2.
4 secondary outcomes
Overall Survival (OS)
Time frame: From TP#2 to death or last follow-up, up to 2 years
Locoregional Recurrence-Free Survival
Time frame: From TP#2 to locoregional recurrence, death, or last follow-up, up to 2 years
Distant Metastasis-Free Survival
Time frame: From TP#2 to distant metastasis, death, or last follow-up, up to 2 years
Lead Time of Molecular Recurrence Detected by ctHPV-DNA
Time frame: Time Frame:
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 24 Aug 2026.
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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.
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 Cervical Cancer and HPV DNA, run by Anhui Provincial Hospital 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 8 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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 Ying Zhou (0551-62283954, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) According to Postoperative ctHPV-DNA Dynamic Status (time frame: From TP#2 to recurrence, death, or last follow-up, up to 2 years). 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 24 Aug 2026.