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Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.

Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.

A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.

CENSURE

Ajay Goel, PhD

Caiming Xu, MD, PhD

Alessandro Mannucci, MD

Man Li

Francesc Balaguer, MD, PhD

Marta Mendiola

This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation.

Adjuvant chemotherapy (ACT) is the standard clinical care for patients with stage III or high-risk stage II colorectal cancer (CRC) after curative-intent resection. Nonetheless, more than 30% of patients experience CRC recurrence. Accurate prediction of recurrence risk in stage II/III CRC patients who undergo ACT is crucial for determining the necessity and duration of ACT, as well as for tailoring novel treatment strategies for these patients.

This study will comprise three phases

1. A systematic and comprehensive CpG methylation-based epigenetic biomarker discovery phase to identify the differentially methylated CpG sites associated with recurrence-free survival (RFS) \< 5 years and \> 5 years. In this phase, LASSO-based machine learning algorithms will be used to optimize the biomarker candidates.
2. A tissue-based clinical assay development phase by quantitative pyrosequencing
3. An independent validation phase.

At completion, this study will validate a tissue-based assay to predict the development of recurrence after the completion of chemotherapy in patients with stage III and II CRC

Formalin-fixed and paraffin-embedded samples derived from the primary tumor.

Stage II/III Colorectal Cancer Recurrence

Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.

Time from treatment completion to development of recurrence (or death)

Time from treatment completion to death from any cause

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Every month we try and update this database with for censure cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for censure

Every month we try and update this database with for censure cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for censure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.