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

NCT03923335 | Not Yet Recruiting

• 1 other identifier: Luo-20190326
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Neoplasms

Keywords

colorectal cancer; prognostic biomarkers; DNA Methylation; gene panel; recurrence; disease free survival

Outcome Measures

Primary Outcomes (1)

• disease free survival

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

  From date of operation until the date of first recurrence or date of death from any cause, whichever came first, assessed up to 5 years

Study Arms (2)

high-risk group

patients with any of the four genes hypermethylated

Other: DNA methylation detection

low-risk group

patients with none of the four genes hypermethylated

Other: DNA methylation detection

Interventions

DNA methylation detection OTHER

detecting the methylation status of colorectal cancer specimen

high-risk group; low-risk group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients that had pathologically verified stage I-II CRC and underwent surgical resection in Sixth Affiliate Hospital of Sun Yat-sen University

You may qualify if:

• TNM stage I-II (T1-4N0M0) colorectal cancer cases
• receive radical surgical resection
• have completed data of tumor location, histological type, behavioral characteristics or TNM staging
• have tumor specimens and either a valid microsatellite instability (MSI) or immuno-histochemistry (IHC) data
• have valid V-raf murine sarcoma viral oncogene homolog B1 (BRAF), kirsten rat sarcoma viral oncogene (KRAS), CpG island methylator phenotype (CIMP) results
• have at least 4 years of follow-up
• have valid time to local recurrence/metastasis in follow-up
• have clinical/treatment record data and valid preoperative status of intestinal obstruction or perforation (IOP), counts of lymph node removed in surgical resection.

You may not qualify if:

• have had a previous diagnosis of any cancer or presence of any tumor other than the CRC
• have had inflammatory bowel disease
• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

tissue specimen from colorectal cancer patients who underwent radical resection

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanxin Luo, MD,PhD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxin Luo, MD,PhD

CONTACT

+86-13826190263; luoyx25@mail.sysu.edu.cn

Du Cai, MD

CONTACT

+86-18819481550; caid6@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 22, 2019
• Study Start: April 30, 2019
• Primary Completion: April 30, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2019

Record last verified: 2019-03

Locations

CN (1)