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NCT Number: NCT06611540

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Carcinoma Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Loading trial locations.

About this study

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 the Roche cobas HPV tests:

Ia. Any high-risk (HR) HPV genotype; Ib. HPV16; Ic. 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 (SOC) colposcopy with cervical 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 purposes of study outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of a cervical sample by clinician

Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Cervical Biopsy

Procedure

Undergo cervical biopsy

colposcopy

Procedure

Undergo colposcopy

Other names: CP

Electronic Health Record Review

Other

Ancillary studies

Endocervical Curettage

Procedure

Undergo endocervical curettage

Excision

Procedure

Undergo cervical excisional procedure

Other names: Abscission, Extirpation, Surgical Removal

HPV Self-Collection

Procedure

Undertake self-collection of vaginal sample

Other names: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

Human Papillomavirus Test

Procedure

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

Other names: HPV Assay, HPV Test, Human Papillomavirus

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Clinical sensitivity for self-collected (SC) samples

    Time frame: One-time, up to 90 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).

  2. Clinical sensitivity for clinician-collected (CC) samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a positive CC sample given CIN2+. Will report point estimate and 95% CIs.

  3. Clinical specificity for SC samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a negative SC sample given < CIN2. Will report point estimate and 95% CIs.

  4. Clinical specificity for CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a negative CC sample given < CIN2. Will report point estimate and 95% CIs.

  5. False positive rate (FPR) for SC samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a positive SC sample given < CIN2. Will report point estimate and 95% CIs.

  6. FPR for CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a positive CC sample given < CIN2. Will report point estimate and 95% CIs.

  7. False negative rate (FNR) for SC samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a negative SC sample given CIN2+. Will report point estimate and 95% CIs.

  8. FNR for CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the probability of a negative CC sample given CIN2+. Will report point estimate and 95% CIs.

  9. Sensitivity ratio for SC versus CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.

  10. Specificity ratio for SC versus CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.

  11. False positive (FP) ratio for SC versus CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.

  12. False negative (FN) ratio for SC versus CC samples

    Time frame: One-time, up to 90 days

    Will be defined as the FNR of SC divided by the FBR of CC. Will report point estimate and 95% CIs.

  13. Positive percent agreement

    Time frame: One-time, up to 90 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.

  14. Negative percent agreement

    Time frame: One-time, up to 90 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.

Other outcomes

  1. Human factors affecting usability

    Time frame: One-time, up to 90 days

    Will be assessed by questionnaire data.

  2. Human factors affecting acceptability

    Time frame: One-time, up to 90 days

    Will be assessed by questionnaire data.

  3. Human factors affecting references for self-collection

    Time frame: One-time, up to 90 days

    Will be assessed by questionnaire data.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S03

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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