Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

N/AActive Not RecruitingNCT06498661

National Cancer Institute (NCI)750 enrolled

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. 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.

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 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, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B) EXPLORATORY OBJECTIVES: I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B) OUTLINE: Patients are assigned to 1 of 2 groups. GROUP A: 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. GROUP B: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may 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 30 days are collected for study analysis purposes.

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of cervical samples by clinician

Cervical BiopsyPROCEDURE

Undergo cervical biopsy conducted by clinician

ColposcopyPROCEDURE

Undergo colposcopy conducted by clinician

Electronic Health Record ReviewOTHER

Ancillary studies

Endocervical CurettagePROCEDURE

Undergo endocervical curettage conducted by clinician

ExcisionPROCEDURE

Undergo cervical excisional procedure conducted by clinician

HPV Self-CollectionPROCEDURE

Undertake self-collection of vaginal samples

Human Papillomavirus TestPROCEDURE

Undergo HPV testing of self-collected vaginal samples and cervical samples

Questionnaire AdministrationOTHER

Ancillary studies

Survey AdministrationOTHER

Ancillary studies

Eligibility

Sex: FEMALEMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * GROUP A: Willingness and ability to provide a documented informed consent * GROUP A: Is 25 years or older * GROUP A: Has an intact cervix * GROUP A: Has had a referral for colposcopy or cervical excisional procedure 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 * GROUP A: 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 * GROUP B: Willingness and ability to provide a documented informed consent * GROUP B: Is 25 years or older * GROUP B: Has an intact cervix * GROUP B: Eligible for regular cervical cancer screening by current national guidelines Exclusion Criteria: * GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months * GROUP A: 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 * GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records * GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation * GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months * GROUP A: Is experiencing unusual bleeding or pelvic pain * GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months * GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit * GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records * GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation * GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months * GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain * GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection

Locations (15)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

...and 5 more locations

Outcomes

Primary Outcomes

Clinical sensitivity for self-collected (SC) samples (Group A)

Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia \[CIN\]2+). Will report point estimate and 95% confidence intervals (CIs).