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

NCT07782697 | Not Yet Recruiting

• 1 other identifier: ZhouYing-ctHPV
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cervical Cancer; HPV DNA

Outcome Measures

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.

  From TP#2 to recurrence, death, or last follow-up, up to 2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  From TP#2 to death or last follow-up, up to 2 years

• Locoregional Recurrence-Free Survival

  From TP#2 to locoregional recurrence, death, or last follow-up, up to 2 years

• Distant Metastasis-Free Survival

  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:

Other Outcomes (2)

• Association Between Quantitative ctHPV-DNA Level and Disease-Free Survival

  ctHPV-DNA assessed at TP#1 and TP#2; DFS assessed for up to 2 years after TP#2

• ctHPV-DNA Clearance After Adjuvant Therapy

  From pre-adjuvant TP#1 assessment to TP#2, approximately 12-16 weeks after completion of adjuvant therapy

Study Arms (1)

HPV-Associated Cervical Cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui province hospital

Hefei, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Ying Zhou

CONTACT

0551-62283954; caddiezy@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

CN (1)