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New blood test could replace scans for HPV cancer patients

NCT ID NCT06640283

Disease control Sponsor: Instituto do Cancer do Estado de São Paulo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a simple blood test that looks for tumor DNA from HPV-related cervical and anal cancers after radiation treatment. The goal is to see if this test can replace expensive imaging scans and help doctors find early signs of cancer returning. If the test is positive, patients may get immunotherapy early to try to improve outcomes. The trial involves 150 adults in Brazil and aims to make the test affordable for public healthcare.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Mar 2025

Expected to finish

Jan 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.

Ages

18 years and older

Sex

Anyone

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: 1. Histological diagnosis of anal canal or cervical cancer. 2. Documented presence of HPV. 3. Locally confined or locally advanced disease, defined as: 1. Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition; 2. Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition. 4. Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy. 5. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1. 6. Age ≥ 18 years. 7. Signing of the Informed Consent Form (ICF). 8. HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200. 9. Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer. Exclusion Criteria: 1. Patients with unequivocal distant metastasis at diagnosis. 2. For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of radiotherapy (with or without chemotherapy) or routine indication for salvage surgery immediately after the conclusion of definitive treatment. 3. Need for recurrent blood transfusions, such as weekly frequency. 4. Another uncontrolled disease representing a life risk, as determined by medical judgment. 5. Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas. 6. Pregnant individuals. 7. Active opportunistic infection or disease. 8. History of autoimmune diseases.

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Conditions

The condition(s) this trial relates to.

anal canal cancer anal squamous cell carcinoma cervical cancer cervical carcinoma cloacogenic carcinoma human papillomavirus-related squamous cell carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Anal canal cancer HPV-related anal squamous cell carcinoma HPV-related carcinoma HPV-related cervical carcinoma Uterine cervical cancer

How to take part

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

  1. The places running it

    1 site. 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

  • Instituto do Câncer do Estado de São Paulo - ICESP

    RECRUITING

    São Paulo, 01246-000, Brazil

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