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Clinical Trials in China / NCT03923335
Starting soon Observational

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

NCT03923335 · tracked via the Priya Life Science China tracker
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Phase
Observational
Started
2019-04-30
Last updated
2019-04-22

Condition(s) studied

Colorectal Neoplasms

Investigational drug(s) / intervention(s)

DNA methylation detection

DNA methylation detection: detecting the methylation status of colorectal cancer specimen

Study summary

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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. TNM stage I-II (T1-4N0M0) colorectal cancer cases 2. receive radical surgical resection 3. have completed data of tumor location, histological type, behavioral characteristics or TNM staging 4. have tumor specimens and either a valid microsatellite instability (MSI) or immuno-histochemistry (IHC) data 5. have valid V-raf murine sarcoma viral oncogene homolog B1 (BRAF), kirsten rat sarcoma viral oncogene (KRAS), CpG island methylator phenotype (CIMP) results 6. have at least 4 years of follow-up 7. have valid time to local recurrence/metastasis in follow-up 8. have clinical/treatment record data and valid preoperative status of intestinal obstruction or perforation (IOP), counts of lymph node removed in surgical resection. Exclusion Criteria: 1. have had a previous diagnosis of any cancer or presence of any tumor other than the CRC 2. have had inflammatory bowel disease 3. have had hereditary colorectal cancer syndromes, including Familial adenomatous polyposis, mutyh (MYH)-associated polyposis, Peutz-Jeghers syndrome, Juvenile polyposis coli, phosphate and tension homology deleted on chromosome ten (PTEN) tumor-hamartoma syndromes, Lynch Syndrome, and Familial Colorectal Cancer Type X.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Sixth Affiliate Hospital of Sun Yat-Sen University Guangzhou Guangdong

More Sixth Affiliated Hospital, Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03923335 on ClinicalTrials.gov ↗ ← All trials in China