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New study aims to improve anal cancer screening for those at highest risk

NCT ID NCT06628570

Diagnosis Sponsor: Lisa Flowers Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study looks at different screening methods to find anal precancer in people at high risk, such as those with weakened immune systems or a history of certain genital cancers. Researchers will compare tests like high-resolution anoscopy, HPV testing, and cell samples to see which works best. The goal is to improve early detection and understand factors linked to the disease.

What this could mean

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

What this could lead to
If successful, this could lead to better, more accurate screening tests for anal precancer in high-risk people, helping catch it early.
What could go wrong
This is an early-stage study focused on comparing screening methods, not testing a treatment. Results may not change current practice immediately.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

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

Started

Dec 2024

Expected to finish

Aug 2028

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.

Ages

30 to 80 years

Sex

Anyone

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: * 30-80 years of age * Individuals with chronic impaired immune status * History of lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2 Exclusion Criteria: * Patients treated for aHSIL less than 6 months before screening * History of anal cancer and pregnant women.

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Conditions

The condition(s) this trial relates to.

anal squamous cell carcinoma neoplasm squamous cell intraepithelial neoplasia anal carcinoma prevention target

As listed by the trial registrant

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

HPV-related anal squamous cell carcinoma Neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • The Ponce Center

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami School of Medicine at Jackson Memorial Hospital (JMH)

    RECRUITING

    Miami, Florida, 33136, United States

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