Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Самостоятельный сбор образцов из шейки матки для тестирования на ВПЧ для улучшения профилактики рака шейки матки (SHIP) (SHIP-A-S01)

26 сентября 2026 г. обновлено: National Cancer Institute (NCI)

Инициатива NCI по раку шейки матки «Последняя миля» «Самостоятельный сбор средств для тестирования на ВПЧ для улучшения профилактики рака шейки матки» (SHIP) Испытание 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.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

750

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

25 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Женский

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Другой: Questionnaire Administration

Ancillary studies

Другой: Survey Administration

Ancillary studies

Другой: Electronic Health Record Review

Ancillary studies

Процедура: Biospecimen Collection

Undergo collection of cervical samples by clinician

Другие имена:
  • Сбор биологических образцов
  • Собран биообразец
  • Сбор образцов
  • Образцы коллекции
Процедура: Cervical Biopsy

Undergo cervical biopsy conducted by clinician

Процедура: Colposcopy

Undergo colposcopy conducted by clinician

Другие имена:
  • КП
Процедура: Endocervical Curettage

Undergo endocervical curettage conducted by clinician

Процедура: Excision

Undergo cervical excisional procedure conducted by clinician

Другие имена:
  • Опадение
  • Искоренение
  • Хирургическое удаление
Процедура: HPV Self-Collection

Undertake self-collection of vaginal samples

Другие имена:
  • Самостоятельный сбор ВПЧ в домашних условиях
  • Самостоятельный сбор ВПЧ
  • Самосбор вируса папилломы человека
Процедура: Human Papillomavirus Test

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

Другие имена:
  • Анализ на ВПЧ
  • Тест на ВПЧ
  • Вирус папилломы человека
Экспериментальный: 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.
Другой: Questionnaire Administration

Ancillary studies

Другой: Survey Administration

Ancillary studies

Другой: Electronic Health Record Review

Ancillary studies

Процедура: Biospecimen Collection

Undergo collection of cervical samples by clinician

Другие имена:
  • Сбор биологических образцов
  • Собран биообразец
  • Сбор образцов
  • Образцы коллекции
Процедура: Cervical Biopsy

Undergo cervical biopsy conducted by clinician

Процедура: Colposcopy

Undergo colposcopy conducted by clinician

Другие имена:
  • КП
Процедура: Endocervical Curettage

Undergo endocervical curettage conducted by clinician

Процедура: Excision

Undergo cervical excisional procedure conducted by clinician

Другие имена:
  • Опадение
  • Искоренение
  • Хирургическое удаление
Процедура: HPV Self-Collection

Undertake self-collection of vaginal samples

Другие имена:
  • Самостоятельный сбор ВПЧ в домашних условиях
  • Самостоятельный сбор ВПЧ
  • Самосбор вируса папилломы человека
Процедура: Human Papillomavirus Test

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

Другие имена:
  • Анализ на ВПЧ
  • Тест на ВПЧ
  • Вирус папилломы человека

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Clinical sensitivity for self-collected (SC) samples (Group A)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: One-time, up to 30 days

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

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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Human factors affecting usability
Временное ограничение: One-time, up to 30 days

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

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

National Cancer Institute (NCI)

Следователи

  • Главный следователь: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

26 июня 2024 г.

Первичное завершение (Оцененный)

30 декабря 2026 г.

Завершение исследования (Оцененный)

30 июня 2027 г.

Даты регистрации исследования

Первый отправленный

10 июля 2024 г.

Впервые представлено, что соответствует критериям контроля качества

11 июля 2024 г.

Первый опубликованный (Действительный)

12 июля 2024 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

26 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NCI-2024-05879
  • NCI-2024-05879 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
  • LMI-001-A-S01 (Другой идентификатор: DCP)
  • LMI-001-A-S01 (Другой идентификатор: National Cancer Institute Division of Cancer Prevention)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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."

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться