Postoperative ctHPV-DNA for Recurrence Prediction and Adjuvant Treatment Decision-Making in Cervical Cancer

Sponsor
Anhui Provincial Hospital
Study ID
NCT07782697
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
580 participants (estimated)

Arms

  • Arm: HPV-Associated Cervical Cancer Cohort

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 ]

Central Contacts

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