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A clinical trials based on SDC2/NDRG4 Gene Methylation Detection Kit (PCR-Fluorescence Probe Method) in vitro diagnostic reagent kit used to qualitative detection of human colorectal cancer genes based on their methylation status.

A clinical trials based on SDC2/NDRG4 Gene Methylation Detection Kit (PCR-Fluorescence Probe Method) in vitro diagnostic reagent kit used to qualitative detection of human colorectal cancer genes based on their methylation status.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075962
Enrollment
Unknown
Registered
2023-09-20
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

Gold Standard:Colonoscopy, Pathological biopsy
Index test:Feces, SDC2/NDRG4 Gene Methylation Detection Kit

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
38 Years to 93 Years

Inclusion criteria

Inclusion criteria: 1: Prospective samples must simultaneously meet the following conditions: ? subjects = 45 years old; ? Those who meet any of the following conditions: (i) have changes in bowel habits and symptoms that meet either of the following two conditions: (1) changes in stool characteristics (such as diarrhea, constipation, mucus stools, etc.); (2) Increased frequency of bowel movements (more than three times a day); (3) History of chronic Appendicitis or Appendicitis resection; (4) History of chronic Cholecystitis or Cholecystitis resection; (5) Unexplained anemia or weight loss; (6) Long term mental depression; (ii) Samples requiring colonoscopy due to suspected other digestive system tumors (such as esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, Cholangiocarcinoma, etc.); (iii) Samples requiring colonoscopy due to suspected other benign diseases of digestive system (such as gastritis, enteritis, Appendicitis, colitis, peptic ulcer, etc.); ? The subjects voluntarily participated in this study and signed a written informed consent form. 2: Retrospective samples: The inclusion of retrospective samples must simultaneously meet the following conditions: ? subjects = 45 years old; ? The results of the colonoscopy examination of the subjects showed positive results for colorectal cancer.

Exclusion criteria

Exclusion criteria: ? Those unable to complete any one of the fecal Genetic testing or colonoscopy ? Subjects have received chemotherapy and other anti-tumor treatment before participating in the study ? Subjects are still participating in other clinical trials within three months before participating in the study ? Subjects samples that the researchers think are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Sensitivity of the Kit in the diagnosis of colorectal cancer;Specificity of the Kit in the diagnosis of colorectal cancer;

Secondary

MeasureTime frame
Sensitivity of the Kit in the diagnosis of colorectal cancer tumors in different stages;The specificity of the kit for various types of adenomas;

Countries

China

Contacts

Public ContactWeidong Liu

Xiangya Hospital of Central South University

1085856815@qq.com+86 138 7312 4855

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026