Neoplasms

Digestive System Diseases

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Symptoms and General Pathology

Colorectal Neoplasms

Recurrence

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Disease Attributes

patients with any of the four genes hypermethylated

patients with none of the four genes hypermethylated

detecting the methylation status of colorectal cancer specimen

DNA methylation detection

Yanxin Luo, MD,PhD

Du Cai, MD

Yanxin Luo, PhD,MD

This study aims to evaluate the predictive value of a four-gene methylation assay called Guangzhou Panel in early-stage colorectal cancer. Patients will be divided into two groups: high risk group and low risk group. The primary endpoint is 5 year disease free survival (DFS).

The current risk stratification system defined by clinicopathological features does not identify the risk of disease recurrence in patients with early-stage colorectal cancer (CRC) with optimal accuracy. The investigators aimed to investigate whether the epigenetic alterations could serve as novel prognostic biomarkers that would improve the accuracy of the current primary tumor, regional nodes, metastasis (TNM) staging system.

In the current study, the Investigators have analyzed the genome-wide methylation status of cytosine-phosphate-guanosine (CpG) sites using Infinium MethylationEPIC array in primary tumor and adjacent normal samples from 23 recurrent and 22 recurrence-free stage I and II CRC patients to identify potential methylation markers for disease-free survival (DFS). The prognostic value of the candidate biomarkers has been evaluated in a training cohort (n=174) and an independent validation cohort (n=267), and is to be validated in a prospective cohort (estimated n=287).

Comprehensive data analysis identified a subset of methylated CpG loci that associated with a high risk of recurrence. Methylated CpGs in four genes were significantly associated with DFS in multivariate analysis in both training and validation cohort. Moreover, Hypermethylated Genes Counts panel using these four markers showed a higher prognostic value than any clinicopathological factor, current molecular biomarkers or single methylated CpG marker alone in the training and validation cohorts. This four-gene methylation assay is defined as Guangzhou Panel.

The investigators aim to conduct a prospective observational study to evaluate the predictive value of Guangzhou Panel in early-stage colorectal cancer. A total of 287 patients with pathologically verified stage I-II CRC and underwent surgical resection are expected to be recruited in our study. These patients will be divided into high-risk group and low-risk group and will be followed up at least 5 years. The primary endpoint is 5-year disease free survival (DFS). The prognostic strength of candidate biomarkers was adjusted in multivariate Cox regression models including multiple biomarkers and clinicopathologic variables.

tissue specimen from colorectal cancer patients who underwent radical resection

The Predictive Value of Guangzhou Panel for Recurrence in Early-stage Colorectal Cancer

Our DNA methylation panel is applying for patent protection, therefore we plan to keep the data private for the time being.

the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Predictive Value of Guangzhou Panel for Recurrence in Early-stage Colorectal Cancer	NCT03923335	Colorectal Neop...	DNA methylation...	40 Years - 70 Years	Sixth Affiliated Hospital, Sun Yat-sen University
The Predictive Value of Guangzhou Panel for Recurrence in Early-stage Colorectal Cancer	NCT03923335	Colorectal Neop...	DNA methylation...	40 Years - 70 Years	Sixth Affiliated Hospital, Sun Yat-sen University

Spots Global Cancer Trial Database for dna methylation detection