Techcyte SureView 子宮頸部細胞診システムの臨床検証研究
細胞診評価のための Techcyte Sureview 子宮頸部細胞診システムとそのサブシステムのパフォーマンスを評価する多施設 2 群臨床研究
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a reference.
The control method is defined as the assessment of LBC pap tests performed by a cytotechnologist (CT) and/or cytopathologist (CP) using standard laboratory cervical cytology practices (i.e. a manual assessment) and following The Bethesda System for Reporting Cervical Cytology (TBS). The control method is referred to as the "standard method".
The test method is referred to as the AI-assisted method. The AI-assisted method is defined as the assessment of the same LBC pap test as in the standard method, but with the Techcyte SureView Cervical Cytology System, which has pap tests being scanned on the Pramana SpectralHT Cubiq whole slide scanner, analyzed with the Techcyte Cervical Cytology Algorithm (TCCA) and presented on the Techcyte Viewer, using the Dell U3223QE Monitor for assessment by a CT/CP following the TBS.
In addition, the time spent reviewing the samples with both methods will be measured such that the CT workload limit for AI-assisted assessment can be established.
The LBC pap tests to be assessed in the clinical study must have been prepared with either ThinPrep® Pap Test (Hologic) or BD SurePath™ (Beckton, Dickinson and Company). The study aims to enroll for each preparation method an equal number of samples.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Utah
-
Orem、Utah、アメリカ、84057
- Techcyte
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Samples collected in the United States
説明
Inclusion Criteria:
- Glass slides with cervical cytology specimens prepared with Hologic ThinPrep according to the pap test manufacturers Instructions for Use (IFU) using any of Hologic's processors (i.e. ThinPrep2000, ThinPrep 3000, ThinPrep 5000, ThinPrep Genesis). OR Glass slides with cervical cytology specimens prepared with BD SurePath according to the pap test manufacturers IFU using any of BD's processors (i.e. BD Totalys MultiProcessor, BD Totalys SlidePrep, BD PrepStain).
- Slide has the original diagnosis available.
- Slides that fit within the required sample size strata using the sample collection procedure.
- Glass slides with QR code, barcodes, or plain text labels.
- Glass slides with coverslips.
- Slides that are 5 years old or less, except where rare specimens require it. Those specimens will have to be reviewed for degradation per the sample collection procedure.
- Only one sample per patient and all are to be collected, processed and scanned.
Exclusion Criteria:
- Broken or cracked slides.
- Slides with air bubbles or scratched, cracked or broken/missing cover slips.
- Slides with markings (e.g., handwritten pen marking) that cannot be removed according to standard laboratory procedures.
- Degraded slides (ex: slides whose stains have lost color or specimens that are not intact).
- Glass slides with cervical cytology specimens prepared with methods other than Hologic ThinPrep or BD SurePath.
- Glass slides with specimens other than cervical cytology specimens.
- Slides from the same patient.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：RETROSPECTIVE
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 |
|---|---|---|
|
Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System
時間枠：1 day
|
The primary objective of the study is to show that the assessment of LBC pap tests using the Techcyte SureView Cervical Cytology System, i.e. the AI-assisted method, is non-inferior to current standard practice, i.e., the standard method, at the LSIL+ threshold used for cytologic diagnosis (specimen adequacy and descriptive diagnosis) as defined by The Bethesda System for Reporting Cervical Cytology. |
1 day
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Nayar R, Wilbur DC. (eds), The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1-VAL-3427
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。