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子宮頸がん予防を改善するための HPV 検査のための子宮頸部サンプルの自己採取 (SHIP) 試験 (SHIP-A-S01)

2026年9月26日 更新者：National Cancer Institute (NCI)

NCI子宮頸がん「ラストマイル」イニシアチブ「子宮頸がん予防を改善するためのHPV検査の自己収集」（SHIP）試験 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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

750

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

25年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：Questionnaire Administration

Ancillary studies

他の：Survey Administration

Ancillary studies

他の：Electronic Health Record Review

Ancillary studies

手順：Biospecimen Collection

Undergo collection of cervical samples by clinician

他の名前：
  • 生物学的サンプルの収集
  • 採取された生体試料
  • 標本収集
  • サンプル収集
手順：Cervical Biopsy

Undergo cervical biopsy conducted by clinician

手順：Colposcopy

Undergo colposcopy conducted by clinician

他の名前：
  • CP
手順：Endocervical Curettage

Undergo endocervical curettage conducted by clinician

手順：Excision

Undergo cervical excisional procedure conducted by clinician

他の名前：
  • 切除
  • 摘出
  • 外科的切除
手順：HPV Self-Collection

Undertake self-collection of vaginal samples

他の名前：
  • 自宅でのHPV自己採取
  • HPV自己採取
  • ヒトパピローマウイルス自己採集
手順：Human Papillomavirus Test

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

他の名前：
  • HPVアッセイ
  • HPV検査
  • ヒトパピローマウイルス
実験的：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.
他の：Questionnaire Administration

Ancillary studies

他の：Survey Administration

Ancillary studies

他の：Electronic Health Record Review

Ancillary studies

手順：Biospecimen Collection

Undergo collection of cervical samples by clinician

他の名前：
  • 生物学的サンプルの収集
  • 採取された生体試料
  • 標本収集
  • サンプル収集
手順：Cervical Biopsy

Undergo cervical biopsy conducted by clinician

手順：Colposcopy

Undergo colposcopy conducted by clinician

他の名前：
  • CP
手順：Endocervical Curettage

Undergo endocervical curettage conducted by clinician

手順：Excision

Undergo cervical excisional procedure conducted by clinician

他の名前：
  • 切除
  • 摘出
  • 外科的切除
手順：HPV Self-Collection

Undertake self-collection of vaginal samples

他の名前：
  • 自宅でのHPV自己採取
  • HPV自己採取
  • ヒトパピローマウイルス自己採集
手順：Human Papillomavirus Test

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

他の名前：
  • HPVアッセイ
  • HPV検査
  • ヒトパピローマウイルス

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Clinical sensitivity for self-collected (SC) samples (Group A)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：One-time, up to 30 days

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

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

その他の成果指標

結果測定
メジャーの説明
時間枠
Human factors affecting usability
時間枠：One-time, up to 30 days

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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Vikrant V Sahasrabuddhe、National Cancer Institute Division of Cancer Prevention

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年6月26日

一次修了 (推定)

2026年12月30日

研究の完了 (推定)

2027年6月30日

試験登録日

最初に提出

2024年7月10日

QC基準を満たした最初の提出物

2024年7月11日

最初の投稿 (実際)

2024年7月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29日

QC基準を満たした最後の更新が送信されました

2026年9月26日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NCI-2024-05879
  • NCI-2024-05879 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • LMI-001-A-S01 (その他の識別子：DCP)
  • LMI-001-A-S01 (その他の識別子：National Cancer Institute Division of Cancer Prevention)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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