Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

Official title

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S04

Overview

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Detailed description

PRIMARY OBJECTIVES:

I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician-collected (CC) samples for the following HPV genotype detections and groupings by Abbott Alinity m high risk (HR) HPV assay:

Ia. Any HR HPV genotype; Ib. HPV16; Ic. HPV16 and/or HPV18; Id. Non-HPV16 high-risk HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68); Ie. Non-HPV16/HPV18 high-risk types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

EXPLORATORY OBJECTIVE:

I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection.

OUTLINE:

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care (SOC) colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one-time), laboratory results available within 60 days are collected for purposes of study outcomes.

Interventions

• Procedure Biospecimen Collection
  Undergo collection of a cervical sample by clinician
• Procedure Cervical Biopsy
  Undergo cervical biopsy
• Procedure Colposcopy
  Undergo colposcopy
• Other Electronic Health Record Review
  Ancillary studies
• Procedure Endocervical Curettage
  Undergo endocervical curettage
• Procedure Excision
  Undergo cervical excisional procedure
• Procedure HPV Self-Collection
  Undertake self-collection of vaginal sample
• Procedure Human Papillomavirus Test
  Undergo HPV testing of self-collected vaginal samples and cervical samples
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Clinical sensitivity for self-collected (SC) samples [Time frame: One-time, up to 60 days]
• Clinical sensitivity for clinician-collected (CC) samples [Time frame: One-time, up to 60 days]
• Clinical specificity for SC samples [Time frame: One-time, up to 60 days]
• Clinical specificity for CC samples [Time frame: One-time, up to 60 days]
• False positive rate (FPR) for SC samples [Time frame: One-time, up to 60 days]
• FPR for CC samples [Time frame: One-time, up to 60 days]
• False negative rate (FNR) for SC samples [Time frame: One-time, up to 60 days]
• FNR for CC samples [Time frame: One-time, up to 60 days]
• Sensitivity ratio for SC versus CC samples [Time frame: One-time, up to 60 days]
• Specificity ratio for SC versus CC samples [Time frame: One-time, up to 60 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Is pregnant when presenting for the referral visit or gave birth within the past 3 months
• Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, 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, preclude study participation
• Previous participation in the SHIP Trial or another cervical cancer screening study within the past 12 months. Participation is defined as completing the self-collection
• Is experiencing unusual bleeding or pelvic pain

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 18 centers

• University of Alabama at Birmingham Cancer Center — Birmingham
• Emory University Hospital/Winship Cancer Institute — Atlanta
• Louisiana State University — Lafayette
• Louisiana State University Health Science Center — New Orleans
• Minneapolis VA Medical Center — Minneapolis
• University of New Mexico Cancer Center — Albuquerque
• Montefiore Medical Center-Einstein Campus — The Bronx
• Montefiore Medical Center-Weiler Hospital — The Bronx
• … and 10 more centers

Identifiers

NCT: NCT07281430 · NCI-2025-09192 · NCI-2025-09192 · LMI-001-A-S04 · LMI-001-A-S04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗