Vlastní odběr vzorků děložního čípku pro testování HPV pro zlepšení prevence rakoviny děložního čípku (SHIP) (SHIP-A-S01)
Iniciativa NCI proti rakovině děložního čípku „Poslední míle“ „Samostatný odběr pro testování HPV pro zlepšení prevence rakoviny děložního čípku“ (SHIP) zkušební verze 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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San Juan, Portoriko, 00936
- University of Puerto Rico
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Alabama
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Birmingham, Alabama, Spojené státy, 35233
- University of Alabama at Birmingham Cancer Center
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Florida
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Miami, Florida, Spojené státy, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital/Winship Cancer Institute
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70112
- Louisiana State University Health Science Center
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Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87106
- University of New Mexico Cancer Center
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New York
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The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- UNC Lineberger Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- University of Cincinnati Cancer Center-UC Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- UPMC-Magee Womens Hospital
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Texas
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Houston, Texas, Spojené státy, 77030
- UT MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, Spojené státy, 23298
- VCU Massey Comprehensive Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
Ostatní jména:
Undergo cervical biopsy conducted by clinician Undergo colposcopy conducted by clinician
Ostatní jména:
Undergo endocervical curettage conducted by clinician Undergo cervical excisional procedure conducted by clinician
Ostatní jména:
Undertake self-collection of vaginal samples
Ostatní jména:
Undergo HPV testing of self-collected vaginal samples and cervical samples
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Undergo cervical biopsy conducted by clinician Undergo colposcopy conducted by clinician
Ostatní jména:
Undergo endocervical curettage conducted by clinician Undergo cervical excisional procedure conducted by clinician
Ostatní jména:
Undertake self-collection of vaginal samples
Ostatní jména:
Undergo HPV testing of self-collected vaginal samples and cervical samples
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical sensitivity for self-collected (SC) samples (Group A)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
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Specificity ratio for SC versus CC samples (Group A)
Časové okno: 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
|
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Difference in clinical specificity between SC and CC samples (Group A)
Časové okno: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
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False positive rate (FPR) for SC samples (Group A)
Časové okno: 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)
Časové okno: 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
|
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FPR ratio for SC versus CC samples (Group A)
Časové okno: 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
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Difference in FPR ratio between SC and CC samples (Group A)
Časové okno: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
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False negative rate (FNR) for SC samples (Group A)
Časové okno: 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
|
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FNR for CC samples (Group A)
Časové okno: 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
|
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FNR ratio for SC versus CC samples (Group A)
Časové okno: 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
|
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Difference in FNR ratio between SC and CC samples (Group A)
Časové okno: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
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Positive percent agreement (Group A)
Časové okno: 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
|
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Negative percent agreement (Group A)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: One-time, up to 30 days
|
Will report point estimate and 95% CIs. |
One-time, up to 30 days
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Human factors affecting usability
Časové okno: One-time, up to 30 days
|
Will be assessed by questionnaire data. |
One-time, up to 30 days
|
|
Human factors affecting acceptability
Časové okno: 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
Časové okno: One-time, up to 30 days
|
Will be assessed by questionnaire data. |
One-time, up to 30 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Patologické procesy
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Atributy nemoci
- Infekce
- Virová onemocnění
- Onemocnění dělohy
- Onemocnění pohlavních orgánů, ženy
- Přenosné nemoci
- Pohlavně přenosné choroby, virové
- Pohlavně přenosné nemoci
- DNA virové infekce
- Genitální novotvary, ženy
- Onemocnění děložního čípku
- Novotvary dělohy
- Nádorové virové infekce
- Patologické stavy, příznaky a symptomy
- Novotvary děložního čípku
- Papilomavirové infekce
- Vyšetřovací techniky
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Chirurgické postupy, operativní
- Minimálně invazivní chirurgické zákroky
- Diagnostické techniky, chirurgické
- Endoskopie
- Urogenitální chirurgické zákroky
- Genetické techniky
- Gynekologické chirurgické zákroky
- Porodní chirurgické zákroky
- Diagnostické techniky, porodnictví a gynekologické
- Molekulární diagnostické techniky
- Manipulace se vzorkem
- Kolposkopie
- Testy lidského papilomaviru DNA
Další identifikační čísla studie
- NCI-2024-05879
- NCI-2024-05879 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- LMI-001-A-S01 (Jiný identifikátor: DCP)
- LMI-001-A-S01 (Jiný identifikátor: National Cancer Institute Division of Cancer Prevention)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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."
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Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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