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Clinical Trial of Human SDC2/SFRP2/TFPI2 Gene Methylation Combined Detection Kit (Fluorescent PCR method)

Clinical Trial of Human SDC2/SFRP2/TFPI2 Gene Methylation Combined Detection Kit (Fluorescent PCR method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077757
Enrollment
Unknown
Registered
2023-11-17
Start date
2022-08-18
Completion date
Unknown
Last updated
2023-11-21

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 and pathological findings
Index test:Human SDC2/SFRP2/TFPI2 Gene Methylation Combined Detection Kit (Fluorescent PCR method)
SDC2/SFRP2/TFPI2 methylation levels in fecal DNA

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were (1)(2)(3)(4) or (1)(2)(3)(5) or (1)(2)(3)(6) : (1) age =18 years and =75 years; (2) no history of colorectal cancer surgery or chemotherapy; (3) consent to participate in the trial; (4) prospective study subjects should meet the following requirements: subjects who are going to undergo colonoscopy and/or pathological examination; (5) retrospective study subjects: subjects with pathologically confirmed colorectal cancer or advanced adenoma; (6) the subjects in the interference group need to satisfy the following requirements: other digestive system tumors or non-digestive system tumors, such as liver cancer, esophageal cancer, gastric cancer, lung cancer, etc. .

Exclusion criteria

Exclusion criteria: (1) Patients with colon cancer with malignancy of other systems or multiple malignancies; (2) patients who had no means of sampling or were ineligible for samples; (3) patients with incomplete medical records (including sex, age, diagnostic information, colonoscopy and/or pathological diagnosis, other demographic data, etc.); (4) subjects who asked to withdraw from clinical trials; (5) patients who were not considered suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Negative and positive consistency rates of combined indicators;

Secondary

MeasureTime frame
Specificity;Sensitivity;

Countries

China

Contacts

Public ContactGang Liu

Tianjin Medical University General Hospital

lg1059@tmu.edu.cn+86 133 8909 8101

Outcome results

None listed

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