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Samodzielne pobieranie wycinków z szyjki macicy do badania na HPV w celu poprawy zapobiegania rakowi szyjki macicy (SHIP) (SHIP-A-S01)

26 września 2026 zaktualizowane przez: National Cancer Institute (NCI)

Inicjatywa NCI Cervical Cancer „Last Mile” „Samodzielne pobieranie testów na obecność wirusa HPV w celu poprawy zapobiegania rakowi szyjki macicy” (SHIP) Próba 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

750

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Portoryko
      • San Juan, Portoryko, 00936
        • University of Puerto Rico
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35233
        • University of Alabama at Birmingham Cancer Center
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • Emory University Hospital/Winship Cancer Institute
    • Louisiana
      • New Orleans, Louisiana, Stany Zjednoczone, 70112
        • Louisiana State University Health Science Center
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87106
        • University of New Mexico Cancer Center
    • New York
      • The Bronx, New York, Stany Zjednoczone, 10461
        • Montefiore Medical Center-Einstein Campus
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • UPMC-Magee Womens Hospital
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
        • UT MD Anderson Cancer Center
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone, 23298
        • VCU Massey Comprehensive Cancer Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

25 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Questionnaire Administration

Ancillary studies

Inny: Survey Administration

Ancillary studies

Inny: Electronic Health Record Review

Ancillary studies

Procedura: Biospecimen Collection

Undergo collection of cervical samples by clinician

Inne nazwy:
  • Pobieranie próbek biologicznych
  • Zebrano próbki biologiczne
  • Kolekcja próbek
Procedura: Cervical Biopsy

Undergo cervical biopsy conducted by clinician

Procedura: Colposcopy

Undergo colposcopy conducted by clinician

Inne nazwy:
  • CP
Procedura: Endocervical Curettage

Undergo endocervical curettage conducted by clinician

Procedura: Excision

Undergo cervical excisional procedure conducted by clinician

Inne nazwy:
  • Odcięcie
  • Wykorzenienie
  • Usunięcie chirurgiczne
Procedura: HPV Self-Collection

Undertake self-collection of vaginal samples

Inne nazwy:
  • Własna kolekcja HPV w domu
  • Własna kolekcja HPV
  • Samodzielne zbieranie wirusa brodawczaka ludzkiego
Procedura: Human Papillomavirus Test

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

Inne nazwy:
  • Test HPV
  • Test na HPV
  • Wirus brodawczaka ludzkiego
Eksperymentalny: 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.
Inny: Questionnaire Administration

Ancillary studies

Inny: Survey Administration

Ancillary studies

Inny: Electronic Health Record Review

Ancillary studies

Procedura: Biospecimen Collection

Undergo collection of cervical samples by clinician

Inne nazwy:
  • Pobieranie próbek biologicznych
  • Zebrano próbki biologiczne
  • Kolekcja próbek
Procedura: Cervical Biopsy

Undergo cervical biopsy conducted by clinician

Procedura: Colposcopy

Undergo colposcopy conducted by clinician

Inne nazwy:
  • CP
Procedura: Endocervical Curettage

Undergo endocervical curettage conducted by clinician

Procedura: Excision

Undergo cervical excisional procedure conducted by clinician

Inne nazwy:
  • Odcięcie
  • Wykorzenienie
  • Usunięcie chirurgiczne
Procedura: HPV Self-Collection

Undertake self-collection of vaginal samples

Inne nazwy:
  • Własna kolekcja HPV w domu
  • Własna kolekcja HPV
  • Samodzielne zbieranie wirusa brodawczaka ludzkiego
Procedura: Human Papillomavirus Test

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

Inne nazwy:
  • Test HPV
  • Test na HPV
  • Wirus brodawczaka ludzkiego

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Clinical sensitivity for self-collected (SC) samples (Group A)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: One-time, up to 30 days

Will report point estimate and 95% CIs.
One-time, up to 30 days
Positive percent agreement (Group A)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: One-time, up to 30 days

Will report point estimate and 95% CIs.
One-time, up to 30 days

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Human factors affecting usability
Ramy czasowe: One-time, up to 30 days

Will be assessed by questionnaire data.
One-time, up to 30 days
Human factors affecting acceptability
Ramy czasowe: 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
Ramy czasowe: One-time, up to 30 days

Will be assessed by questionnaire data.
One-time, up to 30 days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 czerwca 2024

Zakończenie podstawowe (Szacowany)

30 grudnia 2026

Ukończenie studiów (Szacowany)

30 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

10 lipca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 lipca 2024

Pierwszy wysłany (Rzeczywisty)

12 lipca 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NCI-2024-05879
  • NCI-2024-05879 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
  • LMI-001-A-S01 (Inny identyfikator: DCP)
  • LMI-001-A-S01 (Inny identyfikator: National Cancer Institute Division of Cancer Prevention)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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."

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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