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Multi-center, Observational Clinical Trial for SDC2 and LIFR Gene Methylation Detection Kit (Fluorescent PCR Method) in Humans

Multi-center, Observational Clinical Trial for SDC2 and LIFR Gene Methylation Detection Kit (Fluorescent PCR Method) in Humans

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118119
Enrollment
Unknown
Registered
2026-02-02
Start date
2023-05-24
Completion date
Unknown
Last updated
2026-02-09

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:In terms of reagent detection performance, we chose to compare it with Sanger sequencing. In terms of clinical application performance, choose to compare with colonoscopy (and) or pathol
Index test:Human SDC2 and LIFR Gene Methylation Detection Kit (Fluorescent PCR Method)

Sponsors

Hubei Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet one of the following criteria: (1) Clinicians recommend colonoscopy for suspected cases of colorectal cancer or precancerous lesions; (2) Other gastrointestinal cancer patients include gastric cancer, liver cancer, esophageal cancer, bile duct cancer, pancreatic cancer, etc; 2. I voluntarily participate in this clinical trial and have signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Unable to cooperate with the sample collector; 2.The researchers believe that other reasons are not suitable for participants in this experiment.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Total compliance rate;Positive/negative predictive value;Positive/negative likelihood ratio;Kappa value;Positivity rate;Negative concordance rate;

Countries

China

Contacts

Public ContactHu Jianhua

Hubei Cancer Hospital

787732394@qq.com+86 139 7126 9012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026