Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients
調査の概要
詳細な説明
Molecular Profiling/Deep Sequencing:
Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a more detailed type of molecular profile that allows for a more focused analysis of individual genes.
Biomarker Data:
A characteristic that is measured and evaluated as an indicator of normal biologic processes, disease processes or pharmacologic responses to a therapeutic intervention.
Study Participation:
If you agree to take part in this study, information from your medical record will be collected. The information that researchers will collect includes your medical history, chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies you may have had. Your responses to the therapies, your side effects, and the results of any diagnostic tests performed during therapy will also be collected.
Researchers want to learn if they could have better predicted your response to therapy using the information collected in this study and/or better predict side effects from your treatment.
The data collected from your medical record will be stored in a password-protected database at MD Anderson to be used in research related to this study for up to 10 years.
In addition, research studies on new biomarkers may be conducted on your previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
Your name, medical record number, and any other personal identifiable information collected from your medical record will be replaced with a code number. No identifying information will be directly linked to the data collected from your medical record. Only the doctor who is in charge of this study, and select members of their research staff, will have access to the code numbers and be able to link any of the data back to you.
Use of Samples:
Before your banked tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your tissue samples from this bank, must first be approved by the IRB.
Your tissue samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.
Length of Study:
Your participation in this study will be over after either the data, blood, tumor tissue samples, and/or archived tumor samples are analyzed.
This is an investigational study.
Up to 2000 participants will take part in this study. All will be enrolled at MD Anderson.
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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Texas
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Houston、Texas、アメリカ、77030
- 募集
- University of Texas MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
1. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.
Exclusion Criteria:
n/a
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 |
---|---|
Biomarker/Molecular Data Collection and Analyzation
Advanced cancer participants
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Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue.
Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
|
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 |
---|---|---|
Comparison of Biomarker Profiling to Treatment Outcome
時間枠:2 months
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For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable.
Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.
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2 months
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協力者と研究者
捜査官
- 主任研究者:Filip Janku, MD, PHD、M.D. Anderson Cancer 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)
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- LAB10-0441
- 3UL1RR024148-04S1 (米国 NIH グラント/契約)
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。
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