Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
2021年8月31日 更新者：National Jewish Health
Cystic fibrosis (CF) is the most common inherited disease in the western world.
On a yearly basis, 56% of CF patients, or nearly 17,000 individuals in the US, suffer from acute pulmonary exacerbations (APE).
The purpose of this study is to test a candidate assay for its ability to diagnose APE, the most important disease event in CF.
While previous studies have been able to identify biomarkers of CF prognosis and risk stratification, three markers have demonstrated characteristics ideal for APE diagnosis: CD64, TLR2, and GILT.
CD64 is a cellular receptor, expressed on numerous cells of the immune system, whose role is to bind antibodies which are attached to infected cells or pathogens.
TLR2 plays a major role in early host-microbial interactions.
GILT has been shown to be more precise in targeting immune responses against antigens and influences T lymphocyte response.
This study looks to identify the differences in the expression of neutrophil CD64 and CD4+ T cell TLR2 and GILT between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition.
The study also looks to compare sensitivity and specificity of the assays above to standard measures, such as health related quality of life scores (CFQ-R), loss of lung function, white blood cell counts and CRP, for diagnosing acute exacerbations.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
150
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
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Colorado
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Denver、Colorado、アメリカ、80206
- National Jewish Health
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
CF patients aged 18 years or older at the time of an acute pulmonary exacerbation or at baseline health who are followed by the Adult CF Program at National Jewish Health will be eligible to enroll in this study.
説明
Inclusion Criteria:
- Documented diagnosis of CF.
- Age 18 years old or greater.
- Presentation at baseline health OR at the start of treatment for a pulmonary exacerbation of CF.
- Ability to perform reproducible Pulmonary Function Tests
- Ability to produce sputum.
- Willingness to complete a health-related quality of life questionnaire
- Willingness to comply with study procedure and provide written consent.
Exclusion Criteria:
• Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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Acute Pulmonary Exacerbation (APE)
Those subjects presenting with APE will be treated with at least two pathogen specific I.V. antibiotics, as dictated by their treating physician and compliant with standard guidelines for care of an APE.
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Baseline Health
Those subjects presenting at baseline health will be identified by their treating physician as such and will not be starting on any treatments for APE.
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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 |
|---|---|---|
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Difference in neutrophil CD64 expression
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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The primary outcome measure is the difference in expression of neutrophil CD64 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Difference in CD4+ T cell TLR2 expression
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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The primary outcome measure is the difference in expression of CD4+ T cell TLR2 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Difference in GILT expression
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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The primary outcome measure is the difference in expression of GILT as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation of primary outcome measurements with lung function tests
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with changes in FEV1 as measured by spirometry.
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with C-Reactive Protein
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in C-Reactive Protein (CRP)
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with total white blood cell counts
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in total white blood cell counts (WBC).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with sputum inflammatory markers
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in sputum inflammatory markers as measured by sputum neutrophil counts and neutrophil elastase expression.
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with phagocytosis
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in the percentage of phagocytosis by isolated neutrophils.
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
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Correlation of primary outcome measurements with quality of life questionnaire score
時間枠：Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in patient reported health related quality of life scores as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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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
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)
2014年9月10日
一次修了 (実際)
2019年5月23日
研究の完了 (実際)
2021年8月31日
試験登録日
最初に提出
2020年5月18日
QC基準を満たした最初の提出物
2020年5月18日
最初の投稿 (実際)
2020年5月21日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月2日
QC基準を満たした最後の更新が送信されました
2021年8月31日
最終確認日
2021年8月1日
詳しくは
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。