Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
Purpose
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.
Conditions
- Cervical Carcinoma
- Human Papillomavirus Infection
Eligibility
- Eligible Ages
- Over 25 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- The self-collected samples and clinician collected sample have different visual appearances and content. Therefore, by design, the study will have no blinding for participants and study staff. However, a unique study sample label schema will be utilized for both sample types when tested that will not permit linkages or identification of sample pairs thereby permitting unbiased testing and reporting.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prevention (self-collected and clinician-collected samples) |
Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
Lafayette 4330145, Louisiana 4331987 70503
Minneapolis 5037649, Minnesota 5037779 55417
Albuquerque 5454711, New Mexico 5481136 87106
The Bronx 5110266, New York 5128638 10461
Cincinnati 4508722, Ohio 5165418 45219
Oklahoma City 4544349, Oklahoma 4544379 73190
Philadelphia 4560349, Pennsylvania 6254927 19104
Pittsburgh 5206379, Pennsylvania 6254927 15232
Houston 4699066, Texas 4736286 77030
More Details
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Study Contact
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.