Improving Prognostication in Colon Cancer (MARBLE)
Improving Prognostication of Localised Colon Cancer by Combining Liquid Biopsy and Histology: a Multicentric, Prospective Study
The goal of this study is to test better ways to predict if cancer will return after surgery in adults (18+) who have been diagnosed with stage II or III colon cancer.
The main questions it aims to answer are:
- Can computer programs (Artificial Intelligence) and special blood tests give more accurate information about the risk of cancer returning than the methods doctors use today?
- Does combining these new tests help doctors better understand which patients really need chemotherapy and which do not?
Researchers will compare the new computer and blood tests to the standard hospital methods used now to see if the new way is more accurate in predicting the cancer's behavior
Participants will:
- Sign a form saying they agree to take part in the study
- Have their standard surgery to remove the tumor
- Give a few extra teaspoons of blood during their regular, scheduled hospital visits
- Allow researchers to scan and study a small piece of the tumor that was already removed during surgery
- Continue with their normal hospital check-ups for up to five years so researchers can track their health
調査の概要
詳細な説明
The MARBLE study is a prospective, multicentric, single-arm exploratory trial designed to integrate novel tissue- and blood-based prognostic modalities to improve risk stratification for patients with Stage II and III colon cancer. The study evaluates three primary prognostic modalities:
- Pathological Tumor-Node-Metastasis (pTNM) staging
- Machine Learning (ML) Histopathology: A validated graph neural network model analyzes digitized hematoxylin and eosin (H&E) stained slides to generate survival predictions and predict regional gene expression independent of pTNM stage
- Multi-modal ctDNA Assay: An in-house circulating tumor DNA (ctDNA) assay that moves beyond mutation detection by profiling epigenomic markers and genome-wide fragmentomic patterns in cell-free DNA (cfDNA) to enhance sensitivity for minimal residual disease (MRD).
Study Design and Workflow Participants are stratified post-surgery into four treatment-related groups (A-D) that reflect real-world standard-of-care (SoC) pathways rather than randomized arms:
- Group A: Low-risk Stage II (no adjuvant chemotherapy).
- Group B/C: Intermediate to high-risk Stage II/III (3-6 months of adjuvant chemotherapy).
- Group D: High-risk Stage III (6 months of chemotherapy), featuring intensified longitudinal sampling every 6 months for 36 months post-treatment to capture MRD dynamics.
Statistical Approach The primary analysis involves comparing mono-modal and multi-modal risk models to evaluate their prognostic performance for Time to Recurrence (TTR).
Technical evaluation will utilize Cox proportional hazards models, assessing discrimination via ΔC-index, model fit through likelihood ratio testing, and clinical utility using Net Reclassification Improvement (NRI). The study also quantifies the lead time between molecular (ctDNA) and radiological recurrence.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Gertjan Rasschaert, Medical doctor
- 電話番号：+32 16 34 37 91
- メール：gertjan.rasschaert@uzleuven.be
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Male and female participants, at least 18 years of age at the time of signing the Informed Consent Form (ICF).
- Newly diagnosed primary colon tumor clinically and/or histologically consistent with localized colon adenocarcinoma and planned for curative-intent surgical resection.
- Clinical stage compatible with non-metastatic disease at time of screening and considered eligible for standard curative-intent management according to investigator assessment.
- WHO (ECOG) performance status ≤ 3 at baseline.
Exclusion Criteria:
- Participant has been diagnosed with metastatic disease (Stage IV)
- Participant has been diagnosed with rectal cancer
- Participant has been diagnosed with synchronous primary colon tumors (i.e., presence of two or more primary colon tumors detected simultaneously at diagnosis)
- Participant has received prior systemic therapy (chemotherapy, targeted therapy, immunotherapy, or radiotherapy) for colon cancer
- Participation in an interventional Study with an investigational medicinal product (IMP) or device within 30 days prior to inclusion.
- Participant had prior history of colon cancer requiring systemic treatment or major colorectal oncologic surgery.
- Any severe, uncontrolled, or life-threatening medical condition that, in the opinion of the investigator, could interfere with study participation, interpretation of study assessments, or pose excessive risk to the participant (e.g. severe cardiac, hepatic, renal, or uncontrolled infectious disease).
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
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 |
|---|---|---|
|
Time to Recurrence (TTR)
時間枠：Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)
|
The primary outcome measure for the MARBLE study is Time to Recurrence (TTR).
This variable is defined as the time interval from the date of curative-intent surgery to the date of the first documented colon cancer recurrence, whether local or distant.
|
Up to 5 years (the maximum follow-up period for recurrence and survival from the date of surgery or end of adjuvant chemotherapy)
|
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
- S72061
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。