What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors (EXOMA)
The management of cancers and their therapeutic guidance was until shortly mostly based on histopathological considerations of the tumor. the development of targeted therapies is a turning point and keeps increase. These molecules target a specific molecular defect in the tumor making it more effective and more specific treatment. But these treatments are only effective if the tumor has a specific molecular abnormality that is characterized and known.
These therapeutic progresses have been made possible through the decoding of the human genome and the molecular defects occurring during the carcinogenesis process. Now, dozens of therapies targeting a specific molecular abnormality are available in the therapeutic arsenal and dozens more are under development in clinical trials Phase 1 to 3.
In recent years, the democratization of next generation sequencing has opened a new era in cancer research but also for molecular diagnostics. Indeed, the enormous sequencing capabilities offered by high-throughput sequencing technologies allow analysis in a limited time the entire coding sequence of the genome (exome), or even the entire genome of a tumor (whole genome sequencing). Thus, the evolution and the development of broadband and associated bioinformatics tools for genomics techniques now make it possible to establish the genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to propose and specifically targeted direct therapeutic identified genetic alterations and supposedly responsible for tumor development. An analysis of tumor exome by next-generation sequencing (NGS) and provides information on genetic modifications of these tumors.
This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this study is to evaluate the clinical benefit of an analysis of exome performed in current practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by quantifying the number of patients undergoing therapeutic proposal based on the results of the analysis of the profile of the tumor.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Dijon、フランス、21079
- CGFL
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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:
- over 18 years
- histological and cytological diagnosis of solid evidence of malignancy metastatic or locally advanced non-curable and non-curable
- Disease for which a treatment under the national standards do not exist or will not exist if it escapes the current treatment
- Availability of equipment or new tumor biopsy / puncture a feasible accessed injury (biopsiable disease), only if it is deemed necessary in the treatment by the investigator.
- Patient affiliated with a social security scheme
- Patient non opposition
Exclusion Criteria:
- No tumor material available for the establishment of the tumor profile.
- Patient refusal
- Psychiatric illness and / or patient condition compromising the understanding of the information or the conduct of the study
- Patient under guardianship or subject to major people protection regime
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 |
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patient with all types of solid malignant tumors not treatable
In the treatment or assessment of metastatic solid tumor malignancies not curable it can be offered to patients to establish the profile of their tumor by next generation sequencing (NGS).
This technique permits the sequencing of millions of fragments in parallel in a short time and allows to identify rapidly somatic or constitutional mutations known or yet unknown.
The establishment of the genetic profile of the tumor coupled to the available clinical data can help clinicians to predict patient outcome in terms of survival or progression to disease, but may also provide key clues to adapt the management and patient treatment.
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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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Feasibility of exome analysis for patient with a malignant solid tumors
時間枠:1 month
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Feasibility assess by whether or not the patient will have targeted therapeutic
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1 month
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協力者と研究者
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 (実際)
研究の完了 (実際)
試験登録日
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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
その他の研究ID番号
- EXOMA
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