이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

자궁경부암 예방(SHIP) 시험 개선을 위한 HPV 검사를 위한 자궁경부 검체 자가 채취 (SHIP-A-S01)

2026년 9월 26일 업데이트: National Cancer Institute (NCI)

NCI 자궁경부암 '라스트 마일' 이니셔티브 '자궁경부암 예방 개선을 위한 HPV 테스트 자가 채취'(SHIP) 시험 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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

750

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

25년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: Questionnaire Administration

Ancillary studies

다른: Survey Administration

Ancillary studies

다른: Electronic Health Record Review

Ancillary studies

절차: Biospecimen Collection

Undergo collection of cervical samples by clinician

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
절차: Cervical Biopsy

Undergo cervical biopsy conducted by clinician

절차: Colposcopy

Undergo colposcopy conducted by clinician

다른 이름들:
  • CP
절차: Endocervical Curettage

Undergo endocervical curettage conducted by clinician

절차: Excision

Undergo cervical excisional procedure conducted by clinician

다른 이름들:
  • 이탈
  • 근절
  • 외과적 제거
절차: HPV Self-Collection

Undertake self-collection of vaginal samples

다른 이름들:
  • 재택 HPV 자가 수집
  • HPV 자가 수집
  • 인유두종 바이러스 자가 수집
절차: Human Papillomavirus Test

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

다른 이름들:
  • HPV 분석
  • HPV 테스트
  • 인유두종 바이러스
실험적: 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.
다른: Questionnaire Administration

Ancillary studies

다른: Survey Administration

Ancillary studies

다른: Electronic Health Record Review

Ancillary studies

절차: Biospecimen Collection

Undergo collection of cervical samples by clinician

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
절차: Cervical Biopsy

Undergo cervical biopsy conducted by clinician

절차: Colposcopy

Undergo colposcopy conducted by clinician

다른 이름들:
  • CP
절차: Endocervical Curettage

Undergo endocervical curettage conducted by clinician

절차: Excision

Undergo cervical excisional procedure conducted by clinician

다른 이름들:
  • 이탈
  • 근절
  • 외과적 제거
절차: HPV Self-Collection

Undertake self-collection of vaginal samples

다른 이름들:
  • 재택 HPV 자가 수집
  • HPV 자가 수집
  • 인유두종 바이러스 자가 수집
절차: Human Papillomavirus Test

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

다른 이름들:
  • HPV 분석
  • HPV 테스트
  • 인유두종 바이러스

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical sensitivity for self-collected (SC) samples (Group A)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: One-time, up to 30 days

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

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

기타 결과 측정

결과 측정
측정값 설명
기간
Human factors affecting usability
기간: One-time, up to 30 days

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 6월 26일

기본 완료 (추정된)

2026년 12월 30일

연구 완료 (추정된)

2027년 6월 30일

연구 등록 날짜

최초 제출

2024년 7월 10일

QC 기준을 충족하는 최초 제출

2024년 7월 11일

처음 게시됨 (실제)

2024년 7월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 26일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2024-05879
  • NCI-2024-05879 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • LMI-001-A-S01 (기타 식별자: DCP)
  • LMI-001-A-S01 (기타 식별자: National Cancer Institute Division of Cancer Prevention)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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."

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다