An interventional study of Biospecimen Collection and Cervical Biopsy in Cervical Carcinoma and Human Papillomavirus Infection, sponsored by National Cancer Institute (NCI). Active, not recruiting at 14 sites in 2 countries. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Prevention
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 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 the Roche cobas HPV tests: Any high risk (HR) HPV genotype, HPV16, HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (combined).
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 colposcopy with or without 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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
Procedure: Biospecimen Collection · Procedure: Cervical Biopsy · Procedure: Colposcopy · Other: Electronic Health Record Review · Procedure: Endocervical Curettage · Procedure: Excision · Procedure: HPV Self-Collection · Procedure: Human Papillomavirus Test · Other: Questionnaire Administration · Other: Survey Administration
Undergo collection of cervical sample by clinician
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo cervical biopsy conducted by clinician
Undergo colposcopy conducted by clinician
Also known as: CP
Ancillary studies
Undergo endocervical curettage conducted by clinician
Undergo cervical excisional procedure conducted by clinician
Also known as: Abscission, Extirpation, Surgical Removal
Undertake self-collection of vaginal sample
Also known as: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Undergo HPV testing of self-collected vaginal sample and cervical sample
Also known as: HPV Assay, HPV Test, Human Papillomavirus
Ancillary studies
Ancillary studies
Clinical sensitivity for self-collected (SC) samples
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).
Time frame: One-time, up to 90 days
Clinical sensitivity for clinician-collected (CC) samples
Will be defined as the probability of testing HPV positive on CC sample given CIN2+. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
Clinical specificity for SC samples
Will be defined as the probability of testing HPV negative on SC sample given \< CIN2. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
Clinical specificity for CC samples
Will be defined as the probability of testing HPV negative on CC sample given \< CIN2. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
False positive rate (FPR) for SC samples
Will be defined as the probability of testing HPV positive on SC sample given \< CIN2. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
FPR for CC samples
Will be defined as the probability of testing HPV positive on CC sample given \< CIN2. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
False negative rate (FNR) for SC samples
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
FNR for CC samples
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
Sensitivity ratio for SC versus CC samples
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
Specificity ratio for SC versus CC samples
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
False positive (FP) ratio for SC versus CC samples
The FP ratio is the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
False negative (FN) ratio for SC versus CC samples
The FN ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
Time frame: One-time, up to 90 days
Positive percent agreement
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.
Time frame: One-time, up to 90 days
Negative percent agreement
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.
Time frame: One-time, up to 90 days
Human factors affecting usability
Will be assessed by questionnaire data.
Time frame: One-time, up to 90 days
Human factors affecting acceptability
Will be assessed by questionnaire data.
Time frame: One-time, up to 90 days
Human factors affecting preferences for self-collection
Will be assessed by questionnaire data.
Time frame: One-time, up to 90 days
Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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