Brief 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.
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.
Brief Title
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
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 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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Cervical Carcinoma
Human Papillomavirus Infection
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
25 Years
NCT Id
NCT06611540
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
NCI-2024-07724
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial
Primary Outcomes
Outcome Description
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).
Outcome Measure
Clinical sensitivity for self-collected (SC) samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a positive CC sample given CIN2+. Will report point estimate and 95% CIs.
Outcome Measure
Clinical sensitivity for clinician-collected (CC) samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a negative SC sample given \< CIN2. Will report point estimate and 95% CIs.
Outcome Measure
Clinical specificity for SC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a negative CC sample given \< CIN2. Will report point estimate and 95% CIs.
Outcome Measure
Clinical specificity for CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a positive SC sample given \< CIN2. Will report point estimate and 95% CIs.
Outcome Measure
False positive rate (FPR) for SC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a positive CC sample given \< CIN2. Will report point estimate and 95% CIs.
Outcome Measure
FPR for CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a negative SC sample given CIN2+. Will report point estimate and 95% CIs.
Outcome Measure
False negative rate (FNR) for SC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the probability of a negative CC sample given CIN2+. Will report point estimate and 95% CIs.
Outcome Measure
FNR for CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Outcome Measure
Sensitivity ratio for SC versus CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
Outcome Measure
Specificity ratio for SC versus CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
Outcome Measure
False positive (FP) ratio for SC versus CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
Will be defined as the FNR of SC divided by the FBR of CC. Will report point estimate and 95% CIs.
Outcome Measure
False negative (FN) ratio for SC versus CC samples
Outcome Time Frame
One-time, up to 90 days
Outcome Description
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.
Outcome Measure
Positive percent agreement
Outcome Time Frame
One-time, up to 90 days
Outcome Description
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.
Outcome Measure
Negative percent agreement
Outcome Time Frame
One-time, up to 90 days
Secondary Ids
Secondary Id
NCI-2024-07724
Secondary Id
LMI-001-A-S03
Secondary Id
LMI-001-A-S03
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
25
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Einstein
Investigator Email
meinstei@montefiore.org
Investigator Sponsor Organization
External
Study Department
Obstetrics & Gynecology and Women`s Health
Study Division
Gynecologic Oncology
Categories Mesh Debug
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Prostate Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Gynecologic Cancers --- UTERINE CERVICAL DISEASES
Gynecologic Cancers --- UTERINE DISEASES
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES, VIRAL
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES, VIRAL
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
MeSH Terms
UTERINE CERVICAL NEOPLASMS
PAPILLOMAVIRUS INFECTIONS
UTERINE NEOPLASMS
GENITAL NEOPLASMS, FEMALE
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
UTERINE CERVICAL DISEASES
UTERINE DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL DISEASES
SEXUALLY TRANSMITTED DISEASES, VIRAL
SEXUALLY TRANSMITTED DISEASES
COMMUNICABLE DISEASES
INFECTIONS
DNA VIRUS INFECTIONS
VIRUS DISEASES
TUMOR VIRUS INFECTIONS
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SPECIMEN HANDLING
COLPOSCOPY
HUMAN PAPILLOMAVIRUS DNA TESTS
CLINICAL LABORATORY TECHNIQUES
DIAGNOSTIC TECHNIQUES AND PROCEDURES
DIAGNOSIS
INVESTIGATIVE TECHNIQUES
DIAGNOSTIC TECHNIQUES, OBSTETRICAL AND GYNECOLOGICAL
ENDOSCOPY
DIAGNOSTIC TECHNIQUES, SURGICAL
MINIMALLY INVASIVE SURGICAL PROCEDURES
SURGICAL PROCEDURES, OPERATIVE
OBSTETRIC SURGICAL PROCEDURES
GYNECOLOGIC SURGICAL PROCEDURES
UROGENITAL SURGICAL PROCEDURES
MOLECULAR DIAGNOSTIC TECHNIQUES
GENETIC TECHNIQUES