Towards Early Detection of Breast Cancer in High Risk Population (READ RISK)
Robust EArly Detection of bReast Cancer in hIgh riSK Premenopausal Population Using Novel Lipid Based Imaging Methods
Breast cancer is a major and growing health challenge, and the leading cause of cancer in women. As population obesity rates increase, the number of new breast cancer diagnosis continues to rise. Despite treatment advances, breast cancer remains an important cause of premature mortality, taking women in the prime of life. Although underlying susceptibility caused by mutation in the genes including BRCA1/2 is increasingly identified, current pre-symptomatic screening for the general population and those at high genetic risk remains sub-optimal, with high false negative and positive rates.
Alteration of breast lipid composition has been observed by us and others in patients with breast cancer and is thought to precede onset. We have developed and tested a novel method to allow a standard 3T MRI scanner to perform quantitative 3D mapping of specific lipid molecules in the breast.
We will investigate if this method can detect very early breast cancers, and compare the amount and spread of lipid composition in breast tissue of premenopausal women with very high genetic risk of breast cancer, women with breast cancer and women with obesity.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Aberdeenshire
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Aberdeen、Aberdeenshire、イギリス、AB25 2ZD
- Aberdeen Biomedical Imaging Centre
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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:
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Women with BRCA1/2 genes:
- female 18-55 years old, premenopausal
- BRCA 1/2 gene carriers
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
- BMI < 30
Women with breast cancer (no obesity):
- females 18-55 years old, premenopausal
- confirmed diagnosis of invasive ductal carcinoma of the breast
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
- BMI < 30
Women with breast cancer (obesity):
- BMI > 30
- otherwise as women with breast cancer
Women with obesity:
- females 18-55 years old, premenopausal
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
- BMI > 30
Exclusion Criteria:
- females under 18 or over 55 years old, postmenopausal
- males
- have metabolic disorders (e.g., diabetes)
- on long term medications that may affect lipid metabolism (e.g., statins)
- contraindicated for MR investigation (poor renal function and metal implants)
- (for patients) concurrent cancer in other sites
- (for patients) started hormone treatment, chemotherapy or breast surgery
- non-English speakers
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Women with BRCA1/2 genes
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Participants will undertake a magnetic resonance imaging scan.
Participants will undertake a fasting blood test.
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Women with breast cancer
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Participants will undertake a magnetic resonance imaging scan.
Participants will undertake a fasting blood test.
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Women with obesity
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Participants will undertake a magnetic resonance imaging scan.
Participants will undertake a fasting blood test.
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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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Amount of lipid composition in the breast
時間枠：One hour
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The percentage of monounsaturated fatty acids, polyunsaturated fatty acids and saturated fatty acids relative to total lipid will be measured using magnetic resonance imaging (MRI) scanner software and MATLAB computer programme. Unit of Measurement: %. |
One hour
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Spatial distribution (skewness) of lipid composition in the breast
時間枠：One hour
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Skewness measures the asymmetry in distribution. The skewness of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme. Unit of Measurement: unitless. |
One hour
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Spatial distribution (entropy) of lipid composition in the breast
時間枠：One hour
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Entropy measures the randomness in distribution. The entropy of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme. Unit of Measurement: unitless. |
One hour
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Spatial distribution (kurtosis) of lipid composition in the breast
時間枠：One hour
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Kurtosis measures the peakedness in distribution. The kurtosis of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme. Unit of Measurement: unitless. |
One hour
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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 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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。
乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
MRI scanの臨床試験
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Centre hospitalier de l'Université de Montréal...Allergan募集
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Helse Nord-Trøndelag HFNorwegian University of Science and Technology; St. Olavs Hospital完了