肺 EpiCheck バイオマーカー開発研究
This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.
調査の概要
詳細な説明
This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33130
- Life Spring Clinical Research
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Panama City、Florida、アメリカ、32405
- Emerald Coast OBGYN
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Louisiana
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Shreveport、Louisiana、アメリカ、71106
- Ochsner LSU Health Shreveport - Regional Urology
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Michigan
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Southfield、Michigan、アメリカ、48076
- Comprehensive Urology
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Troy、Michigan、アメリカ、48084
- Michigan Institute of Urology, P.C.
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Texas
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San Antonio、Texas、アメリカ、78229
- Urology San Antonio
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Haifa、イスラエル
- Carmel Medical Center
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Tel Aviv、イスラエル
- Sourasky Medical Center
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Hengelo、オランダ
- ZGT Medical Center
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Budapest、ハンガリー
- National Koranyi Institute for Pulmonology
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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
All subjects should be without other cancer in the past 5 years except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
説明
Inclusion Criteria - Cases:
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.
Exclusion Criteria - Cases
- Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer
Inclusion Criteria - USPSTF risk
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
Exclusion Criteria - USPSTF risk
- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Inclusion Criteria - Healthy controls
- Age 20-80 years
- Never smoker or current / previous smoker < 20 pack year history
Exclusion Criteria - Healthy Controls
- Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
- Not previously diagnosed with a lung lesion highly suspicious for cancer
- Under follow up or work up for any lesion suspicious for any type of cancer
- Presenting with fever with body temperature 100.4°F (38°C) or higher
- Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
- Pregnancy
- Any history of blood product transfusion within 30 days prior to blood draw
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：CASE_CONTROL
- 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 |
|---|---|
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Cases Cohort
Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects. |
Blood collection |
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USPSTF At Risk - Control Cohort
Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years. |
Blood collection |
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Healthy Control Cohort
Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years. |
Blood collection |
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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Performance
時間枠：Day 1
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Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value). |
Day 1
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協力者と研究者
スポンサー
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
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。