Advancing Cervical Cancer Screening Through the Emergency Department - IIS

NCT ID: NCT06796738

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cervical cancer screening in the Emergency Department

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be an effort to deploy HPV self-sampling among Emergency Department patients. Emergency Department patients, in the US and worldwide, are disproportionally under-screened for cervical cancer relative to the general population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancers HPV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm - testing

Participants in this arm will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by the study staff on how to self-sample using a defined instructional script written at an elementary reading level, (2) provided with a packaged swab and vial of transport media, and (3) invited to self- sample privately in their ED room or in one of the private ED restrooms.

Group Type OTHER

HPV testing

Intervention Type DIAGNOSTIC_TEST

This study will use the Roche Cobas® 8800 system for HPV testing. The Roche Cobas HPV test is a PCR test that detects 14 hrHPV types and specifically identifies types 16 and 18.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HPV testing

This study will use the Roche Cobas® 8800 system for HPV testing. The Roche Cobas HPV test is a PCR test that detects 14 hrHPV types and specifically identifies types 16 and 18.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cisgender women and transgender/non-binary individuals with a cervix,
* Age 25-65,
* Able to demonstrate decisional capacity to participate.

Exclusion Criteria

* Past hysterectomy with cervical removal,
* Known infection with HIV (as screening recommendations for people with HIV differ from the general population),
* Non-English speaking.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Adler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Rochester

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Study 00010129

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CTCs in Cervix Cancer
NCT04064515 COMPLETED