Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
調査の概要
詳細な説明
It is clear that carcinogenesis is an immensely complex process and that even within a histologic cancer subtype - such as adenocarcinoma of the lung or breast - there is significant heterogeneity in cancer behaviour and response to therapy. Recognizing genetic mutations that promote disease facilitates targeted treatment; this has been demonstrated in several small subgroups of cancers in which specific genetic mutations or translocations have been successfully treated with targeted chemotherapy agents.
Analyses of individual patients demonstrate unique molecular signatures for every cancer examined. Frequently, multiple different pathways are involved in disease growth and progression and the dominant process varies from person to person and perhaps even within different sites of disease within one person. As well these variations evolve in response to treatment. With many recognized mutations personalized evaluation of the genetic signature encoded in DNA and RNA may enable directed therapy to the appropriate oncologic pathway thereby providing information to help guide chemotherapy choices.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ
- BC Cancer Agency
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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
説明
Inclusion Criteria:
- Subjects must have histologically or cytologically confirmed diagnosis of cancer
- This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage).
- Subjects must agree to provide archival tissue and agree to undergo a study specific biopsy and blood test for genetic analysis. All subjects would have a biopsy and blood samples at progression if it could be done safely.
- ECOG PS 0 or 1.
- Age > 18 years of age.
- Subject consent must be obtained according to the BCCA requirements.
- Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site.
Exclusion Criteria:
- Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA.
- Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.
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
- 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)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Sequenced patients
Patients enrolled on the study who have successful sequencing of their cancers will be closely monitored for: what chemotherapy agents are next used, what response and toxicity do they have, is there any early sign of response detected on PET-CT, overall did the genomic information change treatment decision-making.
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Fresh tumour biopsies and matched normal specimens (blood and surrounding tissue) and when possible archival pretreatment specimens, will undergo in depth DNA and RNA sequencing and analysis on an oncogene panel.
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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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Frequency of actioanble genomic abnormalites detected that modify treatment
時間枠:up to 24 months
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What is the frequency of "actionable" results in this varied tumour population ?
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up to 24 months
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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 |
|---|---|---|
|
What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test
時間枠:up to 24 months
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What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
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up to 24 months
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協力者と研究者
捜査官
- 主任研究者:Janessa J. Laskin, MD FRCPC、British Columbia Cancer Agency
- 主任研究者:Marco Marra, PhD FRSC、Genome Sciences Centre, BC Cancer Agency
出版物と役立つリンク
一般刊行物
- Peixoto RD; Li Y; Pleasance E; Yip S; et al. A case of the utilization of genomic information in the management of metastatic colorectal cancer. J Clin Oncol 30: 2012 (suppl 34; abstr 444)
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。