HPV 検出における乾式綿棒と湿式綿棒を使用した自己採取の比較 (HPV)
CIN2+病変をスクリーニングするためのhrHPV DNAの検出において、乾燥状態で輸送された自己採取膣サンプルと湿った状態で輸送された膣サンプルの性能を比較する臨床研究
This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.
調査の概要
詳細な説明
Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined.
This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA using LBC and as reference standard.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Nairobi County
-
Nairobi、Nairobi County、ケニア、00100
- Kenya Medical Research Institute (KEMRI)
-
-
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
Participants are eligible to be included in the study only if all of the inclusion criteria and none of the exclusion criteria indicated below apply.
Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.
説明
Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site:
- Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy)
- Able to understand scope of study
- Able to provide written informed consent
- Willing to provide all necessary samples
Exclusion Criteria:
- Vaccinated for HPV
- Pregnancy
- Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)
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：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Cohort of sexually active adult females with an abnormal cervical cancer screening result.
Multi-center, prospective, paired, comparative diagnostic accuracy study To compare the performance of self-collected vaginal samples transported dry to those transported wet for detection of hrHPV DNA. Interventions: COPAN floq swab transported wet and dry evaluated on Roche COBAS and Cepheid Xpert HPV tests |
COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs
他の名前：
|
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 |
|---|---|---|
|
To compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR on health care provider-collected cervical samples as the reference standard.
時間枠：6 Months
|
Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR as the reference standard. |
6 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compare the performance of self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.
時間枠：6 Months
|
Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard. |
6 Months
|
|
Compare the performance of self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.
時間枠：6 Months
|
Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard. |
6 Months
|
|
Compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.
時間枠：6 Months
|
Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected dry swabs to self-collected wet swabs for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard. |
6 Months
|
|
Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.
時間枠：6 Months
|
Assessment of survey responses using descriptive statistics. |
6 Months
|
|
Assess the usability of self-collection amongst women and to assess the usability of self-collection using vaginal dry swabs compared to self-collection using vaginal wet swabs and provider collection methods for HPV testing amongst health care workers.
時間枠：6 Months
|
Assessment of survey responses using descriptive statistics. |
6 Months
|
協力者と研究者
協力者
捜査官
- スタディディレクター：Angela Muriuki、Foundation for Innovative New Diagnostics (FIND)
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 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- WH001
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。