がんの強い家族歴を持つ患者におけるがんの早期検出のための全身磁気共鳴画像法とリキッドバイオプシーの分析
全身MRIとリキッドバイオプシーによるがんの早期発見
This study evaluates patient acceptability of whole body magnetic resonance imaging (WBM) and liquid biopsies (LB) in detecting early stage cancer in patients with a strong family history of cancer. Collecting family history and testing for genes passed on from parent to child (germline testing) can be used to predict the likelihood of a patient developing cancer. Currently, detection of early cancers focuses on screening specific organ systems such as breast and colon cancer. Magnetic resonance imaging (MRI) uses a large magnet and radio waves to look at organs and structures inside the body. Health care professionals use MRI scans to diagnose a variety of conditions, from torn ligaments to cancer. Liquid biopsy is test that analyzes blood samples to determine if cancer cells are present. This study may help researchers determine the feasibility of WBM and liquid biopsies to detect early stage cancer in patients that have a strong family history of cancer.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
PRIMARY OBJECTIVE:
I. To assess the acceptability of the approach of LB and WBM.
SECONDARY OBJECTIVES:
I. Determine the prevalence of WBM findings requiring additional imaging or invasive testing.
II. Determine the effect of germline testing, LB, and WBM on psychological distress and health-related quality of life (HR-QOL) at 6 months after testing compared with baseline.
EXPLORATORY OBJECTIVE:
I. Determine correlation between high-risk LB findings and cancer detected on WBM.
OUTLINE: This is an observational study.
Patients undergo WBM without contrast, blood sample collection for liquid biopsy, and complete surveys on study. Germline testing may also be performed on blood sample collected as standard of care or using the Precision Medicine protocol (Institutional Review Board [IRB] 96144).
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
-
参加基準
適格基準
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
説明
Inclusion Criteria:
- Age >= 50 years, or age within 10 years of first degree relative with cancer at age of diagnosis (as long as age is >= 18)
- Have a strong family history of cancer ( >= 2 first-degree relatives with cancer, one first and second degree relative with cancer in one lineage (side of family), or at least three first or second degree relatives with cancer in one lineage (side of the family). Non-melanoma skin cancer excluded from family history eligibility
- Have a family history of early-onset cancer (age >40) in at least one first-degree relative
- Willing to have 50 mL of blood (approximately 3.5 tablespoons) drawn (40 ml if germline testing already performed)
- Able to undergo MRI (no implants, metal, or claustrophobia that would preclude MRI)
- Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer
- Positron emission tomography/computed tomography (PET/CT) or other whole body imaging modality (including combination of CT chest and abdomen) within 3 years
- No signs/symptoms of possible cancer (e.g. hemoptysis, breast mass, blood per rectum, unexplained weight loss)
- Willing to undergo standard of care genetic counseling and germline testing, or has already undergone genetic counseling and germline testing
- Documented informed consent of the participant
Exclusion Criteria:
- Unable to provide informed consent
- Contraindications to MRI (implants, metal, or claustrophobia that would preclude MRI)
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
- 主な目的：ふるい分け
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy |
Undergo blood sample collection
他の名前：
Complete surveys Undergo germline testing
他の名前：
Undergo liquid biopsy testing
他の名前：
Undergo whole body MRI without contrast
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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM)
時間枠：Up to 6 months after WBM
|
Acceptability, as measured by the survey question "How satisfied are you with the research study overall?" and is defined as a score of 4 ("moderately acceptable) or 5 ("highly acceptable"). |
Up to 6 months after WBM
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of WBM findings requiring additional imaging or invasive testing
時間枠：Up to 6 months after WBM
|
Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage. |
Up to 6 months after WBM
|
|
Psychological distress (Germline testing)A
時間枠：Up to 6 months after WBM
|
The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (Germline testing)B
時間枠：Up to 6 months after WBM
|
The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (Liquid Biopsy)A
時間枠：Up to 6 months after WBM
|
The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (Liquid Biopsy)B
時間枠：Up to 6 months after WBM
|
The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (WBM)A
時間枠：Up to 6 months after WBM
|
The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (WBM)B
時間枠：Up to 6 months after WBM
|
The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Health Related Quality of Life (HRQOL/Germline)
時間枠：Up to 6 months after WBM
|
The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Health Related Quality of Life (HRQOL/LB)
時間枠：Up to 6 months after WBM
|
The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Health Related Quality of Life (HRQOL/WBM)
時間枠：Up to 6 months after WBM
|
The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlation between high-risk liquid biopsy findings and cancer detected on WBM
時間枠：Up to 6 months after WBM
|
Liquid biopsy (LB) test sensitivity and specificity calculated by comparing the LB results with the WBM results, with WBM results considered the gold standard. Confusion matrix statistics, such as positive predictive value, negative predictive value, and test accuracy examined. Results reported with their corresponding 95% confidence intervals. |
Up to 6 months after WBM
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Dan Raz、City of Hope Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- 21574
- P30CA033572 (米国 NIH グラント/契約)
- 21574 (その他の識別子：City of Hope Medical Center)
- NCI-2022-01829 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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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