肺がんの低線量CTスクリーニング陽性後に追跡画像検査を受ける患者におけるSmall RNA血液検査の診断性能
肺がんの低線量 CT スクリーニング陽性後にフォローアップ画像検査を受けている患者における Small RNA 血液検査の診断性能「Small RNA の特徴に基づく肺がんの早期検出 - ボストン II」
2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
調査の概要
詳細な説明
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.
Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.
Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30342
- Northside Hospital
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
- Our Lady of the Lake Regional Medical Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Mass General Hospital
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Boston、Massachusetts、アメリカ、02108
- Brigham and Women's Hospital
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Worcester、Massachusetts、アメリカ、01655
- UMass Chan Medical School/UMass Memorial Health
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Health
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New York
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Queens、New York、アメリカ、10461
- New York Health + Elmhurst Hospitals
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The Bronx、New York、アメリカ、10461
- Jacobi Medical Center
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Pennsylvania
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DuBois、Pennsylvania、アメリカ、15801
- Clinical Research Associates of Central PA
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Texas
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Beaumont、Texas、アメリカ、77701
- Baptist Hospitals of Southeast Texas
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Utah
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Salt Lake City、Utah、アメリカ、84112
- University Of Utah Health
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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
Individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
説明
Inclusion Criteria:
- Adult male and female patients, aged 50 to 80 years
- Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
- Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
- Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
- Able and willing to provide informed consent
Exclusion Criteria:
- Prior history of diagnosed lung cancer
- History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
- Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
- Immunosuppressive medication
- Deemed not able to participate in the study by the investigator
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 |
|---|---|
|
Participants undergoing diagnostic evaluation following positive LDCT screening
Participants undergoing further diagnostic evaluation following a positive LDCT lung cancer screening result. A blood sample is collected at enrollment, prior to any invasive diagnostic procedure or treatment, for evaluation of a small RNA-based lung cancer assay. Participants are followed to determine the final clinical diagnosis. |
At study enrollment, a blood sample is collected prior to any invasive diagnostic procedure or treatment. A small RNA-based lung cancer assay is performed on the collected blood sample for research purposes. Assay results are not returned to participants or investigators and are not used for clinical decision-making. |
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 |
|---|---|---|
|
Primary Objective
時間枠：1 year
|
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study. |
1 year
|
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 (推定)
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
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。