NCI Cervical Cancer 'Last Mile' Initiative 'Self-collection for HPV Testing to Improve Cervical Cancer Prevention

M.D. Anderson Cancer Center

Status: Not yet enrolling

Conditions: HPV (Human Papillomavirus)-Associated

Treatments: Procedure: Human Papillomavirus

Study type: Observational

Funder types: Other

Identifiers

NCT06676150

NCI-2024-09086 (Other Identifier)

2024-1336

Details and patient eligibility

About

To look at the results from a sample collected for human papillomavirus (HPV) testing similar or the same as the results from the cervical sample collected by a doctor.

Full description

Primary Objectives:

To evaulate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC Samples for the following HPV genotype detections and groupings:

• Any HR HPV genotype
• HPV16
• Other individual HR HPV and/or assay-specific channels/pooled genotypes

Enrollment: 500 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Willingness and ability to provide a documented informed consent.
• Is 25 years of older.
• Has an intact cervix.
• Has had a referral for colposcpoy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screeing, co-testing, or ASC-US cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit.
• Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or cervical excisional procedure, as applicable.

Exclusion Criteria

An individiual meeting the following criteria will be ineligible for participation in the study:

• Is pregnant when presenting for the referal visit or gave birth within the past three months.
• Has known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherpay, thermal ablation) in the last 12 months prior to the referral visit.
• Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records.
• Known medical conditions that, in the opinion of the investigator, prelude study participation.
• Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.

Trial design

500 participants in 1 patient group

Human Papillomavirus

Description:

The goal of this study is to prove that a self-collected sample might be as accurate as a clinician-collected sample collected during a visit to the doctor. In the initial part of the study, also known as the pilot phase, a limited number of participants may participate to understand the best way to get the study started and collect and process the specimens. These participants may only participate in some, but not all activities as discussed below.

Treatment:

Procedure: Human Papillomavirus