Measurement of Circulating Tumor Cells in Prostate Cancer (ICELLATEPC)
調査の概要
詳細な説明
Prostate cancer is the most common form of cancer in men and the second most deadly. Today's diagnostic methods and treatments are therefore obviously not adequate. In this study we will evaluate a new diagnostic sampling and analysis method for prostate cancer, not try new treatments. The test sampling involves the rare tumor cells and tumor DNA found in the blood, and sequencing their DNA to determine which, if any, defective genes they contain that may explain the disease. There is currently no universally accepted diagnostic test of either tumor cells or tumor DNA in blood. We have access to new technology that one of us (CE) developed at the Karolinska Institute, which by all accounts can give access to the rare tumor cells in the blood so that we can sequence their DNA. In this study we want to try to see if it is possible in practical healthcare to apply the new technology for prostate cancer patients and if there are signs that it works equally well in the healthcare environment as in the laboratory.
Impact: If the sampling of tumor cells and tumor DNA from blood samples works within the healthcare system processes, it will be possible to understand the causal relationships behind their occurrence, and their gene defects, we can design follow-up studies that would take us closer to clinical use of the new technology to predict which treatment would be most effective and which treatment would produce the least side effects.
Ethical considerations: The risks of blood sampling are limited and known and can be managed within the healthcare system. Data is handled safely. The potential future benefit of a new cancer cell- and DNA-test is great.
The study is a collaboration between Region Sörmland, Karolinska Institutet and iCellate Medical AB. The data collection is expected to be completed in 2020 and the analyses in 2021.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Sormland
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Eskilstuna、Sormland、スウェーデン、631 88
- Mälarsjukhuset
-
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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:
- patients diagnosed with prostate cancer of moderate risk planned for prostatectomy with lymph node removal, or
- patients diagnosed with prostate cancer stage 3, or
- patients with diagnosed prostate cancer stage 4, or
- patients with diagnosed benign inflammatory prostatitis or other benign urological condition constituting age-matched, cancer free, controls
Exclusion Criteria:
- Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)
- Patients with previous malignancy
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：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Localised prostate cancer
Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
|
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Stage 3 prostate cancer
Patients with diagnosed stage 3 prostate cancer
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
|
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Stage 4 prostate cancer
Patients with diagnosed stage 4 prostate cancer
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
|
|
Healthy controls
Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition
|
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
|
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 |
|---|---|---|
|
Single cell DNA sampling
時間枠：September 2019 to December 31st, 2020
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Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?
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September 2019 to December 31st, 2020
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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 |
|---|---|---|
|
Comparison of novel sampling results to established biomarkers
時間枠：September 2019 to December 31st, 2020
|
Is it possible to understand the causal link between the presence and amounts of tumor cells and tumor DNA in the blood by reviewing the patient's medical records, including information on investigations, analysis reports and diagnosis?
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September 2019 to December 31st, 2020
|
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Single cell DNA sequencing
時間枠：September 2019 to December 31st, 2020
|
Can acquired gene defects that may predict treatment be detected by sequencing individual tumor cells, or break-down products, from blood samples?
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September 2019 to December 31st, 2020
|
協力者と研究者
捜査官
- スタディディレクター：Evangelos Digkas, MD, PhD、Region Sörmland
出版物と役立つリンク
一般刊行物
- Castro et al., Surgery Curr Res 2012, 2:3 http://dx.doi.org/10.4172/2161-1076.1000113
- Castro et al., J Integr Oncol 2018, 7:3 DOI: 10.4172/2329-6771.1000212
- Castro et al., Disease Markers Volume 2018, Article ID 4653109, 5 pages https://doi.org/10.1155/2018/4653109
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
本研究に関する用語
その他の研究ID番号
- 2019-02592
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?
IPD プランの説明
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
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。