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Can a new test cut unnecessary biopsies for HPV-Positive women?

NCT ID NCT07777094

Diagnosis Sponsor: Affiliated Hospital of Nantong University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study evaluates a new test called TS (Triple Staining) to see how accurately it can identify which women with high-risk HPV actually have cervical precancerous lesions. Researchers will compare TS results against the gold standard of colposcopy and biopsy in 300 women, and will also follow up with those who test positive on TS but have no lesions on biopsy. The goal is to determine if TS can reliably triage patients, potentially reducing unnecessary invasive procedures.

What this could mean

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

Active substance
TS (Triple Staining) test, a diagnostic procedure used to triage women with high-risk HPV
What this could lead to
If successful, this could lead to a more accurate, less invasive way to decide which HPV-positive women need further examination, reducing unnecessary procedures and anxiety.
What could go wrong
The test's accuracy may vary across different HPV types and viral loads, and false positives could still lead to unnecessary procedures. The study is relatively small and results may not apply to all populations.

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 300 people

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

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 who visited the gynecological outpatient department of the Affiliated Hospital of Nantong University between October 2024 and October 2026, and were detected as positive for high-risk human papillomavirus (HR-HPV) in cervical cancer screening through the Hybrid Capture 2 (HC2) technique, and had indications for colposcopic evaluation, and were scheduled for colposcopy or cervical pathological biopsy, as well as those patients who had both the HPV viral load test results and the Triple Staining (TS) results in our hospital and were awaiting colposcopy, will be selected.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Patients in our outpatient clinic who have already undergone HPV viral load testing and are awaiting colposcopy, or those who have both HPV viral load test results and TS (Triple Staining) results and are awaiting colposcopy； 2. Informed consent obtained from voluntary participants. Exclusion Criteria: 1. Patients who are unable to cooperate or have poor compliance; 2. Within four months postpartum; 3. During the first three days of menstruation with heavy flow; 4. Within three months after cervical surgery (including cervical biopsy); 5. Previous radiotherapy in the pelvic region; 6. Currently undergoing chemotherapy or within five weeks after chemotherapy; 7. Clinically evident acute or subacute cervical/vaginal infection; 8. History of photosensitivity disorders, current photodynamic therapy, or exposure to photosensitizing agents; 9. Suspected or confirmed history of alcohol/drug abuse, or any other condition that-in the investigator's judgment-may reduce enrollment feasibility or complicate participation (e.g., frequent job relocation, unstable living conditions leading to high risk of loss to follow-up); 10. Other patients deemed ineligible by the investigators.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical intraepithelial neoplasia Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical cancer Cervical precancerous lesions

Contacts and locations

Locations

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001, China

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