Autocolección de muestras de cuello uterino para la prueba del VPH para mejorar el ensayo de prevención del cáncer de cuello uterino (SHIP) (SHIP-A-S01)
Iniciativa del NCI sobre cáncer de cuello uterino 'Última milla' 'Autocolección de pruebas de VPH para mejorar la prevención del cáncer de cuello uterino' (SHIP) Ensayo LMI-001-A-S01
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
- Otro: Questionnaire Administration
- Otro: Survey Administration
- Otro: Electronic Health Record Review
- Procedimiento: Biospecimen Collection
- Procedimiento: Cervical Biopsy
- Procedimiento: Colposcopy
- Procedimiento: Endocervical Curettage
- Procedimiento: Excision
- Procedimiento: HPV Self-Collection
- Procedimiento: Human Papillomavirus Test
Descripción detallada
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 Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B)
EXPLORATORY OBJECTIVES:
I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B)
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
GROUP B: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
After completion of study intervention (one time), laboratory results available within 30 days are collected for study analysis purposes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham Cancer Center
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital/Winship Cancer Institute
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Louisiana State University Health Science Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- University of New Mexico Cancer Center
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New York
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The Bronx, New York, Estados Unidos, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- UNC Lineberger Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Cancer Center-UC Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC-Magee Womens Hospital
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Texas
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Houston, Texas, Estados Unidos, 77030
- UT MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- VCU Massey Comprehensive Cancer Center
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San Juan, Puerto Rico, 00936
- University of Puerto Rico
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- GROUP A: Willingness and ability to provide a documented informed consent
- GROUP A: Is 25 years or older
- GROUP A: Has an intact cervix
- GROUP A: Has had a referral for colposcopy or cervical excisional procedure 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
- GROUP A: 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
- GROUP B: Willingness and ability to provide a documented informed consent
- GROUP B: Is 25 years or older
- GROUP B: Has an intact cervix
- GROUP B: Eligible for regular cervical cancer screening by current national guidelines
Exclusion Criteria:
- GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
- GROUP A: 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
- GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- GROUP A: Is experiencing unusual bleeding or pelvic pain
- GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
- GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
- GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain
- GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. |
Ancillary studies Ancillary studies Ancillary studies Undergo collection of cervical samples by clinician
Otros nombres:
Undergo cervical biopsy conducted by clinician Undergo colposcopy conducted by clinician
Otros nombres:
Undergo endocervical curettage conducted by clinician Undergo cervical excisional procedure conducted by clinician
Otros nombres:
Undertake self-collection of vaginal samples
Otros nombres:
Undergo HPV testing of self-collected vaginal samples and cervical samples
Otros nombres:
|
|
Experimental: Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. |
Ancillary studies Ancillary studies Ancillary studies Undergo collection of cervical samples by clinician
Otros nombres:
Undergo cervical biopsy conducted by clinician Undergo colposcopy conducted by clinician
Otros nombres:
Undergo endocervical curettage conducted by clinician Undergo cervical excisional procedure conducted by clinician
Otros nombres:
Undertake self-collection of vaginal samples
Otros nombres:
Undergo HPV testing of self-collected vaginal samples and cervical samples
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical sensitivity for self-collected (SC) samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia [CIN]2+). Will report point estimate and 95% confidence intervals (CIs). |
One-time, up to 30 days
|
|
Clinical sensitivity for clinician-collected (CC) samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV positive on CC sample given disease positive (e.g., CIN2+). Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Sensitivity ratio for SC versus CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Difference in clinical sensitivity between SC and CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Clinical specificity for SC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV negative on SC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Clinical specificity for CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV negative on CC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Specificity ratio for SC versus CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Difference in clinical specificity between SC and CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
False positive rate (FPR) for SC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV positive on SC sample given < CIN2. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
FPR for CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV positive on CC sample given < CIN2. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
FPR ratio for SC versus CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
The FPR ratio is the FPR of SC divided by the FP of CC. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Difference in FPR ratio between SC and CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
False negative rate (FNR) for SC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
FNR for CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
FNR ratio for SC versus CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
The FNR ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Difference in FNR ratio between SC and CC samples (Group A)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Positive percent agreement (Group A)
Periodo de tiempo: One-time, up to 30 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. |
One-time, up to 30 days
|
|
Negative percent agreement (Group A)
Periodo de tiempo: One-time, up to 30 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. |
One-time, up to 30 days
|
|
Positive percent agreement (Group A and Group B)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Negative percent agreement (Group A and Group B)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Cohen's Kappa (Group A and Group B)
Periodo de tiempo: One-time, up to 30 days
|
Will be described as a measure of agreement beyond chance between SC and CC samples, and values will be interpreted as follows: 0.00-0.19 as poor, 0.20-0.39 as fair, 0.40-0.59 as moderate, 0.60-0.79 as good, and 0.80-1.00 as excellent agreement beyond chance. Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Test positivity rates (Group A and Group B)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
|
Rate of invalid test results (Group A and Group B)
Periodo de tiempo: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Human factors affecting usability
Periodo de tiempo: One-time, up to 30 days
|
Will be assessed by questionnaire data. |
One-time, up to 30 days
|
|
Human factors affecting acceptability
Periodo de tiempo: One-time, up to 30 days
|
Will be assessed by questionnaire data. |
One-time, up to 30 days
|
|
Human factors affecting references for self-collection
Periodo de tiempo: One-time, up to 30 days
|
Will be assessed by questionnaire data. |
One-time, up to 30 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Procesos Patológicos
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Atributos de la enfermedad
- Infecciones
- Enfermedades virales
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por virus de ADN
- Neoplasias Genitales Femeninas
- Enfermedades del cuello uterino
- Neoplasias Uterinas
- Infecciones por virus tumorales
- Condiciones Patológicas, Signos y Síntomas
- Neoplasias del cuello uterino
- Infecciones por virus del papiloma
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos mínimamente invasivos
- Técnicas de diagnóstico, quirúrgico
- Endoscopia
- Procedimientos quirúrgicos urogenitales
- Técnicas genéticas
- Procedimientos quirúrgicos ginecológicos
- Procedimientos quirúrgicos obstétricos
- Técnicas de diagnóstico, obstétricos y ginecológicos
- Técnicas de diagnóstico molecular
- Manejo de muestras
- Colposcopia
- Pruebas de ADN del papiloma humano
Otros números de identificación del estudio
- NCI-2024-05879
- NCI-2024-05879 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- LMI-001-A-S01 (Otro identificador: DCP)
- LMI-001-A-S01 (Otro identificador: National Cancer Institute Division of Cancer Prevention)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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."
Información sobre medicamentos y dispositivos, documentos del estudio
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