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Blood test may flag cervical cancer return after surgery

NCT ID NCT07782697

Knowledge-focused Sponsor: Anhui Provincial Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study is testing whether a simple blood test that detects HPV DNA from tumor cells can help predict if cervical cancer will come back after surgery. Researchers will collect blood samples before surgery and at two time points afterward from about 580 patients with early-stage cervical cancer. They will track patients over time to see if changes in this DNA marker are linked to cancer recurrence and survival. The goal is to see if this test could one day help doctors decide who needs extra treatment and who might safely skip it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood test measuring circulating tumor HPV DNA (ctHPV-DNA)
What this could lead to
If successful, this blood test could help doctors predict who is at higher risk of cervical cancer returning after surgery, potentially guiding more personalized treatment decisions.
What could go wrong
This is an observational study, so it won't prove the test changes outcomes. The test may not reliably predict recurrence, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 580 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer HPV DNA

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Anhui province hospital

    Hefei, China

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