CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy (CANDIDATE)
調査の概要
詳細な説明
The investigators produce customized gene target panel by selecting genes that are commonly found in colorectal cancer and metastasis from existing literature.
In patients diagnosed with lung metastases from colorectal cancer, 20mL of whole blood is collected before and after local treatment (surgery or radiation) and cell-free DNA (cfDNA) is extracted from the collected blood. Thereafter, 20 mL of whole blood is additionally collected once after 3 months (±2 months) and once after 6 months (±2 months) during follow-up and cfDNA is extracted. The investigators perform sequencing from the extracted cfDNA.
The investigators compare the mutations detected in cfDNA before and after local treatment and identify the trend of reducing mutations in cfDNA after local treatment. So The investigators discover biomarkers for the outcome of local treatment. The investigators also search for mutations for target drugs from mutation profiling of cfDNA.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Seung-Tae Lee
- 電話番号：82-2-2228-2446
- メール：LEE.ST@yuhs.ac
研究場所
-
-
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Seoul、大韓民国
- Department of Laboratory Medicine, Yonsei University College of Medicine
-
コンタクト：
- Seung-Tae Lee
- 電話番号：82-2-2228-2446
- メール：LEE.ST@yuhs.ac
-
-
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:
- adults over 19 years of age
- those who understand research and have written consent
- cases diagnosed with lung metastases from colorectal cancer
Exclusion Criteria:
- pregnant women, nursing women
- those who lack the ability to voluntarily agree
- participation in other clinical trials where drugs for clinical trials are administered within the past four weeks as of the date of participation in clinical trials
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 |
|---|---|
|
Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation)
patients diagnosed with lung metastases from colorectal cancer and undergoing surgery or radiation for lumg metastasis
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detection of tumor DNA alteration in cf-DNA
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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 |
|---|---|---|
|
correlation between circulating tumor DNA (ctDNA) before and after local treatment (surgery or radiation) and recurrence of lung metastases from colorectal cancer
時間枠：about 6 month but additional extension for patients with relapse after local treatment
|
The investigations investigate whether ctDNA changes and f/u ctDNA fraction after local treatment (surgery or radiation) can be useful as markers to predict the outcome of local treatments.
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about 6 month but additional extension for patients with relapse after local treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
mutations related to target drug
時間枠：about 6 month but additional extension for patients with relapse after local treatment
|
The investigations check for target drug related mutations from mutation profiling of ctDNA.
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about 6 month but additional extension for patients with relapse after local treatment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Seung-Tae Lee、Severance Hospital
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
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。