Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
- Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.
OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.
Patients' enzyme expression levels are compared with their clinical data.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Tokyo、日本、113-8519
- Tokyo Medical and Dental University
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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>
- Pathologically confirmed stage III colon adenocarcinoma
- Curatively resected (R0)
- Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
- Provided written informed consent
<Exclusion criteria>
- Synchronous or metachronous multiple cancers
- Contraindications for fluorouracil-based chemotherapy
- Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study
- Ineligible patients according to the investigator's judgement
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
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 |
時間枠 |
|---|---|
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Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
時間枠：5 years after the end of registration
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5 years after the end of registration
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Relationship between expression levels of enzymes and adverse effects
時間枠：5 years after the end of registration
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5 years after the end of registration
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Disease-free survival
時間枠：Until the day on which an event reveals during the 5 year observational period
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Until the day on which an event reveals during the 5 year observational period
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Relapse-free survival
時間枠：Until the day on which an event reveals during the 5 year observational period
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Until the day on which an event reveals during the 5 year observational period
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協力者と研究者
捜査官
- 主任研究者：Kenichi Sugihara, MD, PhD、Tokyo Medical and Dental University
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
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 (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
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