Neoplasms

Digestive System Diseases

All Conditions

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

Sixth Affiliated Hospital, Sun Yat-sen University

Genetic Predisposition to Disease

Disease Susceptibility

one genetic consultation and one blood test

blood sample

Laurence FAIVRE, PH

Emilie REDERSTORFF

Marie-Agnès COLLONGE-RAME

Emilie REDERSTORFF, PhD

François GHIRINGHELLI, PU PH

Laurence FAIVRE

Monique MOZELLE

Frederique CARRE-PIGEON

5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.

The main objective of this study is to evaluate the interest of the SHD-E approaches after a negative result of the analysis called " gene panel " tested in routine in order to identify a genetic factor of predisposition to the cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer	NCT04141462	Cancer Genetic Predisp...	blood sample	18 Years -	Centre Georges Francois Leclerc
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 gene panel

Every month we try and update this database with for gene panel 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.

Spots Global Cancer Trial Database for gene panel

Every month we try and update this database with for gene panel 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 gene panel 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.