Clinical trial NCT06498661: Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
Official title: NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Carcinoma
Human Papillomavirus Infection
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2024-07-12
Enrollment: 520
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal 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. 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 OBJECTIVE:

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 Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66.

EXPLORATORY OBJECTIVE:

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

OBJECTIVE FOR PILOT PHASE:

I. The emphasis in the pilot phase of the study will be on streamlining and refining study procedures and clinical and operational workflows.

OUTLINE:

Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one time), laboratory results available within 90 days are collected for study analysis purposes.

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 and/or cervical excisional procedure in which routine cervical cancer screening has included 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
* 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. Participation is defined as completing the self-collection
* Is experiencing unusual bleeding or pelvic pain

Primary outcomes:
measure: Clinical sensitivity for self-collected (SC) samples
timeFrame: One-time, up to 90 days
measure: Clinical sensitivity for clinician-collected (CC) samples
timeFrame: One-time, up to 90 days
measure: Clinical specificity for SC samples
timeFrame: One-time, up to 90 days
measure: Clinical specificity for CC samples
timeFrame: One-time, up to 90 days
measure: False positive rate (FPR) for SC samples
timeFrame: One-time, up to 90 days
measure: FPR for CC samples
timeFrame: One-time, up to 90 days
measure: False negative rate (FNR) for SC samples
timeFrame: One-time, up to 90 days
measure: FNR for CC samples
timeFrame: One-time, up to 90 days
measure: Sensitivity ratio for SC versus CC samples
timeFrame: One-time, up to 90 days
measure: Specificity ratio for SC versus CC samples
timeFrame: One-time, up to 90 days
measure: False positive (FP) ratio for SC versus CC samples
timeFrame: One-time, up to 90 days
measure: False negative (FN) ratio for SC versus CC samples
timeFrame: One-time, up to 90 days
measure: Positive percent agreement
timeFrame: One-time, up to 90 days
measure: Negative percent agreement
timeFrame: One-time, up to 90 days
Secondary outcomes:
Other outcomes:
measure: Human factors affecting usability
timeFrame: One-time, up to 90 days
measure: Human factors affecting acceptability
timeFrame: One-time, up to 90 days
measure: Human factors affecting references for self-collection
timeFrame: One-time, up to 90 days
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Cancer Center
state: Alabama
city: San Francisco
country: United States
facility: UCSF Medical Center-Parnassus
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Louisville
country: United States
facility: UofL Health Medical Center Northeast
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: New York
country: United States
facility: NYP/Weill Cornell Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center-UC Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-Magee Womens Hospital
state: Pennsylvania
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center - Northwest
state: Washington
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: National Cancer Institute Division of Cancer Prevention
name: Vikrant V Sahasrabuddhe
role: PRINCIPAL_INVESTIGATOR
References: