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

Condition(s) studied

Investigational drug(s) / intervention(s)

Biospecimen Collection: Undergo collection of a cervical sample by clinician

Cervical Biopsy: Undergo cervical biopsy

Colposcopy: Undergo colposcopy

Electronic Health Record Review: Ancillary studies

Endocervical Curettage: Undergo endocervical curettage

Excision: Undergo cervical excisional procedure

HPV Self-Collection: Undertake self-collection of vaginal sample

Human Papillomavirus Test: Undergo HPV testing of self-collected vaginal samples and cervical samples

Questionnaire Administration: Ancillary studies

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Clinical sensitivity for self-collected (SC) samples — One-time, up to 60 days
  Will be defined as the probability of a positive SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).
• Clinical sensitivity for clinician-collected (CC) samples — One-time, up to 60 days
  Will be defined as the probability of a positive CC sample given CIN2+. Will report point estimate and 95% CIs.
• Clinical specificity for SC samples — One-time, up to 60 days
  Will be defined as the probability of a negative SC sample given \< CIN2. Will report point estimate and 95% CIs.
• Clinical specificity for CC samples — One-time, up to 60 days
  Will be defined as the probability of a negative CC sample given \< CIN2. Will report point estimate and 95% CIs.
• False positive rate (FPR) for SC samples — One-time, up to 60 days
  Will be defined as the probability of a positive SC sample given \< CIN2. Will report point estimate and 95% CIs.
• FPR for CC samples — One-time, up to 60 days
  Will be defined as the probability of a positive CC sample given \< CIN2. Will report point estimate and 95% CIs.
• False negative rate (FNR) for SC samples — One-time, up to 60 days
  Will be defined as the probability of a negative SC sample given CIN2+. Will report point estimate and 95% CIs.
• FNR for CC samples — One-time, up to 60 days
  Will be defined as the probability of a negative CC sample given CIN2+. Will report point estimate and 95% CIs.
• Sensitivity ratio for SC versus CC samples — One-time, up to 60 days
  Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
• Specificity ratio for SC versus CC samples — One-time, up to 60 days
  Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
• False positive (FP) ratio for SC versus CC samples — One-time, up to 60 days
  Will be defined as the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
• False negative (FN) ratio for SC versus CC samples — One-time, up to 60 days
  Will be defined as the FNR of SC divided by the FBR of CC. Will report point estimate and 95% CIs.
• Positive percent agreement — One-time, up to 60 days
  Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.
• Negative percent agreement — One-time, up to 60 days
  Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.

Trial sites (18)

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