Blood test could spot cervical cancer return earlier

NCT ID NCT04574635

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a blood test can find DNA from the HPV virus that causes cervical cancer. Researchers will collect blood samples from 18 people with cervical cancer before, during, and after treatment. The goal is to see if the test can predict how well treatment works and detect if the cancer comes back sooner than standard methods.

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 a simple blood test to monitor cervical cancer and catch recurrences earlier.
What could go wrong: This is a very small, early-stage study with only 18 participants, so results may not apply to all patients. The test may not be sensitive enough to detect all cancers.

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

18 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Nov 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

Women ages 18 and older presenting with p16-positive or HPV-positive invasive carcinoma of the cervix cancer with plan to undergo therapy at Mayo Clinic Rochester or the University of Minnesota.

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: * Able to provide written consent * Patient has given permission to give tumor/blood sample for research testing * Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix * Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV * Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits * Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis * Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC) * FIGO 2019 Stage IB2-IIIC or not a surgical candidate * Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy Exclusion Criteria: * Other active malignancy =\< 2 years prior to registration. * EXCEPTIONS: Non-melanotic skin cancer * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer * Pregnancy or lactation * Inability on the part of the patient to understand the informed consent to be compliant with the protocol

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Conditions

The condition(s) this trial relates to.

cervical adenosquamous carcinoma cervical cancer cervical carcinoma cervical squamous cell carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Blood test could spot cervical cancer return earlier

What the study statuses mean