NCT07782697Not yet recruiting
Postoperative ctHPV-DNA for Recurrence Prediction and Adjuvant Treatment Decision-Making in Cervical Cancer
Dynamic ctHPV-DNA Monitoring After Radical Surgery for Cervical Cancer to Predict Recurrence Risk and Guide Adjuvant Treatment Decisions: An Exploratory Clinical Study
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 580 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07782697
What you commit to
- Study type: Observational
- Planned participants: 580
- From Sept 2026 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pelvic radiotherapy administered before radical surgery.
- Concurrent active HPV-associated malignancy other than cervical cancer.
Other illness
- HPV-independent cervical cancer, including gastric-type adenocarcinoma or confirmed HPV-negative squamous cell carcinoma.
Other
- No residual cervical tumor after conization and inability to establish a reliable baseline HPV target for ctHPV-DNA monitoring.
- Inability to comply with the scheduled blood collection or follow-up procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Province Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.