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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HPV (Human Papillomavirus)-Associated
• Intervention / Treatment: Procedure: Human Papillomavirus

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Elizabeth Y Chiao, MD; Phone Number: 713-792-1860; Email: eychiao@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
      • Principal Investigator: Elizabeth Y Chiao, MD
      • Contact: Elizabeth Y Chiao, MD; Phone Number: 713-792-1860; Email: eychiao@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Human Papillomavirus; 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.

Procedure: Human Papillomavirus; Human papillomavirus (HPV) testing is usually done at the doctor's office. The doctor or nurse puts a metal or plastic speculum into your vagina to see your cervix. Then they gently use a sampler (a small brush or spatula) to take small number of cells from your cervix to test for HPV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression Free Survival	Through study completion; an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2024-1336; NCI-2024-09086 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No