The Liver in the World Trade Center Health Program General Responder Cohort and Controls
調査の概要
詳細な説明
This is a prospective cross-sectional study of liver disease in individuals who meet the United States Preventive Services Task Forces guidelines for lung cancer screening because they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. Liver disease will be compared between individuals who are members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort. The basic objective is to determine whether exposure to the WTC attack increased liver disease.
Data will be obtained from the World Trade Center Data Center, from Mount Sinai Medical records, EPIC, the data warehouse, and from data collected by the Lung Cancer Screening Program of Dr. Henschke. Results of genetic tests that relate to liver disease will be collected from the medical record.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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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
説明
Inclusion Criteria:
- Male or Female between 55 and 80 years of age
- 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years.
- Individuals who are members of the World Trade Center General Responder Cohort or Subjects who meet the United States Preventive Services Task Forces guidelines for lung cancer screening
Exclusion Criteria:
- None
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：ケースコントロール
- 時間の展望：断面図
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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General Responder Cohort (GRC) WTC Responders
General Responder Cohort (GRC) and who have chosen to undergo annual medical monitoring and treatment of their WTC-related conditions at Mount Sinai's Irving J. Selikoff Center for Occupational and Environmental Medicine (SCOEM), which is directed by Dr. M. Crane
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A non-invasive diagnostic device used to measure liver scarring
他の名前：
CT scan as part of routine research care
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General Responder Cohort (GRC) Non WTC Responders
Members of the World Trade Center General Non Responder Cohort.
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A non-invasive diagnostic device used to measure liver scarring
他の名前：
CT scan as part of routine research care
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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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FibroScan- Controlled Attenuation Parameter (CAP) scores
時間枠：Day 1
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assesses liver fat using a patented technique called Vibration-Controlled Transient Elastography range from 0 -400 CAP with the higher number indicating great quantity of fat in the Liver CAP 240-270 S1 Mild Steatosis CAP 270-300 S2 Moderate Steatosis CAP >300 S3 Severe Steatosis
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Day 1
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Attenuation Hounsfeld units signal intensity in low -dose non-contrast CT scan
時間枠：Day 1
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The attenuation of Hounsfeld units (HU) signal intensity in low-dose non-contrast CT to estimate liver fibrosis
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Day 1
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Fibroscan
時間枠：Day 1
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assesses liver stiffness using a patented technique called Vibration-Controlled Transient Elastography. Results are measured using kiloPascal's (or kPa) and range from 2 to 75kPa, with a higher number indicating more liver scarring. F0 Zero 5.3 kPa means no scarring F1 5.3-7.0 kPa is mild fibrosis F2 is 7.1-8.0 kPa moderate fibrosis F3 8.1-12.4 kPa is severe fibrosis F4 greater than 12.5 kPa is cirrhosis or advanced fibrosis, |
Day 1
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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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Relationship between WTC exposure and liver fat
時間枠：Day 1
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The Controlled Attenuation Parameter (CAP) scores using a Multiple linear regression modeling to determine whether WTC exposure is significantly associated with liver fat content after adjusting for potential confounding factors ,smoking history, diabetes and BMI.
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Day 1
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Composite score for Fibrosis and Steatosis
時間枠：Day 1
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Composite score from Fibroscan to compare for exposure to WTC site Clinically significant fibrosis will be defined as Fibroscan >8.0kPa and Steatosis will be defined as a Fibroscan CAP >300dB/m indicating advance steatosis <7.9 kPa score Zero , >8.0 kPa score 1, <299 CAP will score Zero, >300 CAP will score 1 Range of total score Zero -2 equals best to worst scoring
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Day 1
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協力者と研究者
捜査官
- 主任研究者：Andrea Branch, PhD、Icahn School of Medicine at Mount Sinai
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
追加の関連 MeSH 用語
その他の研究ID番号
- GCO 16-2612
- U01OH011489-01 (米国 NIH グラント/契約)
- IF 1991038 (その他の識別子：Icahn School of Medicine at Mount Sinai)
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
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