ctDNA and TEP Levels in Colon Cancer
Determination of ctDNA and TEP Levels in Patients With Colon Cancer Receiving Neoadjuvant Systemic Therapy
This interventional cohort study will evaluate circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP) as blood-based biomarkers in adults with stage III colon cancer who are planned to receive neoadjuvant systemic therapy followed by surgical resection.
Treatment will be given according to routine clinical practice and will depend on the biological characteristics of the tumor, including mismatch repair status. Participants will provide additional blood samples at predefined time points before, during, and after treatment and surgery. These samples will be used to analyze ctDNA and TEP and to assess whether changes in these biomarkers are associated with radiological response, pathological response, and disease-free outcomes.
Approximately 80 participants will be enrolled at the Institute of Oncology Ljubljana. Participants will not receive experimental drugs as part of this study.
調査の概要
状態
条件
詳細な説明
This is a prospective interventional longitudinal cohort study of adult patients with histologically confirmed stage III colon adenocarcinoma who are planned to receive neoadjuvant systemic therapy followed by surgical resection with curative intent.
The study will evaluate the dynamics of circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP) during neoadjuvant treatment and follow-up. Neoadjuvant systemic therapy will be selected according to routine clinical practice and tumor biology, including mismatch repair status. Patients with pMMR tumors may receive chemotherapy, while patients with dMMR tumors may receive immunotherapy, according to standard clinical decision-making.
The research intervention consists of additional peripheral venous blood sampling at predefined time points before treatment, during systemic treatment, before surgery, and after surgery. Blood samples will be analyzed for ctDNA and TEP-based biomarkers. Clinical, radiological, pathological, and follow-up data will be collected from routine medical documentation.
The primary objective is to determine whether the presence of ctDNA after completion of neoadjuvant systemic therapy is associated with pathological tumor response, defined as major pathological response (MPR), in patients with stage III colon cancer. Secondary and exploratory objectives include evaluation of the association between ctDNA, TEP profiles, radiological response, recurrence-free outcomes, and disease-free outcomes.
Approximately 80 participants will be enrolled. The study is academic and non-commercial. Participants will not receive experimental drugs as part of this study, and all therapeutic and diagnostic procedures will follow established clinical practice.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tanja Mesti, MD
- 電話番号：+386 1 5879 287
- メール：tmesti@onko-i.si
研究場所
-
-
-
Ljubljana、スロベニア、1000
- Institute of Oncology Ljubljana
-
コンタクト：
- Klavdija Korošec
- 電話番号：+38631630065
- メール：kkorosec@onko-i.si
-
コンタクト：
- Tanja Mesti, MD
- 電話番号：+386 1 5879 287
- メール：tmesti@onko-i.si
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years or older at the time of enrollment.
- Histologically confirmed adenocarcinoma of the colon.
- Stage III colon cancer, defined according to the applicable TNM classification based on clinical and imaging assessment.
- Confirmed mismatch repair (MMR) status, determined by immunohistochemistry and/or molecular methods.
- Planned neoadjuvant systemic therapy according to MMR status, followed by surgical resection with curative intent.
- ECOG performance status 0-2.
- Ability to understand the study and provide written informed consent.
Exclusion Criteria:
- Stage I, II, or IV colon cancer.
- Concurrent active malignant disease, except adequately treated non-melanoma skin cancer or carcinoma in situ.
- Severe comorbidities or medical conditions that prevent or substantially limit neoadjuvant systemic therapy or surgical resection.
- Known autoimmune disease requiring active immunosuppressive treatment in patients with dMMR tumors.
- Pregnancy or breastfeeding.
- Inability or unwillingness to provide written informed consent.
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
- 主な目的：診断
- 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 |
|---|---|
|
他の：Biomarker Assessment Cohort
Participants with stage III colon cancer receiving neoadjuvant systemic therapy according to routine clinical practice will undergo additional peripheral venous blood sampling at predefined time points for ctDNA and TEP biomarker analysis.
|
Additional peripheral venous blood samples will be collected at predefined time points before treatment, during systemic treatment, before surgery, and after surgery.
Samples will be analyzed for circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP).
|
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 |
|---|---|---|
|
Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
時間枠：From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Major pathological response will be assessed by histopathological evaluation of the surgical resection specimen after completion of neoadjuvant systemic therapy.
The unit of measure will be the percentage of participants with major pathological response.
ctDNA status after completion of neoadjuvant systemic therapy will be used as a pre-specified stratification variable in the statistical analysis.
|
From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Objective Radiological Response According to RECIST 1.1
時間枠：From baseline to preoperative radiological assessment, approximately 3 to 6 months.
|
Radiological response will be assessed according to RECIST version 1.1 using routine preoperative imaging.
Objective radiological response will include complete response and partial response.
The unit of measure will be the percentage of participants with objective radiological response.
ctDNA status after completion of neoadjuvant therapy will be used as a pre-specified stratification variable in the statistical analysis.
|
From baseline to preoperative radiological assessment, approximately 3 to 6 months.
|
|
Percentage of Participants Alive and Disease-Free at 12 Months After Surgical Resection
時間枠：12 months after surgical resection.
|
Disease-free status will be assessed using routine clinical, radiological, and follow-up documentation.
The outcome will be defined as being alive and without disease recurrence at 12 months after surgical resection.
The unit of measure will be the percentage of participants alive and disease-free at 12 months.
ctDNA status after completion of neoadjuvant therapy will be used as a pre-specified stratification variable in the statistical analysis.
|
12 months after surgical resection.
|
|
Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative ctDNA Assessment
時間枠：Up to 12 months after surgical resection.
|
Early disease recurrence will be assessed using routine clinical, radiological, and follow-up documentation.
The unit of measure will be the percentage of participants with disease recurrence within 12 months after surgical resection.
Postoperative ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
|
Up to 12 months after surgical resection.
|
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Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative TEP Assessment
時間枠：Up to 12 months after surgical resection.
|
Early disease recurrence will be assessed using routine clinical, radiological, and follow-up documentation.
The unit of measure will be the percentage of participants with disease recurrence within 12 months after surgical resection.
Postoperative tumor-educated platelet status will be used as a pre-specified stratification variable in the statistical analysis.
|
Up to 12 months after surgical resection.
|
|
Percentage of Participants With Major Pathological Response in the Baseline ctDNA Assessment
時間枠：From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Major pathological response will be assessed by histopathological evaluation of the surgical resection specimen.
The unit of measure will be the percentage of participants with major pathological response.
Baseline ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
|
From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
|
Percentage of Participants With Pathological Complete Response After Surgical Resection
時間枠：From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Pathological complete response will be assessed by histopathological evaluation of the surgical resection specimen.
The unit of measure will be the percentage of participants with pathological complete response.
Baseline ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
|
From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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
- ORI2026-25
個々の参加者データ (IPD) の計画
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