Postoperative ctHPV-DNA for Recurrence Prediction and Adjuvant Treatment Decision-Making in Cervical Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAnhui Provincial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
580 Participants
are grouped into 1 trial groupGroup A: HPV-Associated Cervical Cancer Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
From TP#2 to recurrence, death, or last follow-up, up to 2 yearsSecondary outcomes
1
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.
Time frame
From TP#2 to death or last follow-up, up to 2 years2
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.
Time frame
From TP#2 to locoregional recurrence, death, or last follow-up, up to 2 years3
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.
Time frame
From TP#2 to distant metastasis, death, or last follow-up, up to 2 years4
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.
Time frame
Time Frame:Other outcomes
1
Association Between Quantitative ctHPV-DNA Level and Disease-Free Survival
Quantitative ctHPV-DNA levels will be analyzed as a continuous variable to evaluate their association with DFS. ctHPV-DNA values will be log10-transformed for statistical modeling.
Time frame
ctHPV-DNA assessed at TP#1 and TP#2; DFS assessed for up to 2 years after TP#22
ctHPV-DNA Clearance After Adjuvant Therapy
Among evaluable patients receiving postoperative adjuvant therapy, ctHPV-DNA clearance will be assessed by comparing ctHPV-DNA status before adjuvant treatment with that at TP#2. The association between ctHPV-DNA clearance and DFS will also be explored.
Time frame
From pre-adjuvant TP#1 assessment to TP#2, approximately 12-16 weeks after completion of adjuvant therapySponsors and contacts
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Source ClinicalTrials.gov
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