Blood tests for HPV DNA after surgery to predict cervical cancer return
Follows HPV DNA in blood after surgery in adults with cervical cancer.
Plain-language title generated from the registry record
Registry title: Postoperative ctHPV-DNA for Recurrence Prediction and Adjuvant Treatment Decision-Making in Cervical Cancer
Key facts
- Where
- Hefei, ChinaSee the site
Where in China
- Anhui Province HospitalHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anhui Provincial Hospital
- Trial code
- NCT07782697
- Record updated
- 24 August 2026
- Original description
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 full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: Pelvic radiotherapy administered before radical surgery; Concurrent active HPV-associated malignancy other than cervical cancer; HPV-independent cervical cancer, including gastric-type adenocarcinoma or confirmed HPV-negative squamous cell carcinoma; 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.