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Multi-center Clinical Trial of Methylation Detection Kit for SDC2 Gene (Real Time PCR) (Product Name: ColoSafe)

Clinical Trial of Methylation Detection Kit for SDC2 Gene (Real Time PCR)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026409
Enrollment
Unknown
Registered
2019-10-08
Start date
2017-05-15
Completion date
Unknown
Last updated
2019-10-14

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 examination
Detection&#32
Kit&#32
for&#32
Gene&#32
(Real&#32
PCR)(Product&#32
ColoSafe)

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 87 Years

Inclusion criteria

Inclusion criteria: 1. Patients with colorectal cancer; 2. Patients with suspected colorectal cancer; 3. Patients with digestive diseases such as guilt and polyps, and other cancer; 4. Healthy people; Inclusion criteria of supplementary clinical trial: 1. Interfering sample:Subject with other diseases or physiological conditions other than colorectal cancer, including but not limited to gastritis, gastric cancer, esophagitis, rheumatoid arthritis, prostate cancer, microbes (inflammation patients), gastrointestinal bleeding, drugs (typical digestive tract medication) Population), neuroendocrine cancer, squamous cell carcinoma (squamous squamous cell carcinoma, esophageal squamous cell carcinoma); 2. Follow-up sample subjects: Subjects who underwent resection of colorectal cancer lesions for at least 3 months in a prior clinical trial.

Exclusion criteria

Exclusion criteria: 1. Sample containing berberine; 2. Patients who discontinued the trial due to other systemic diseases during the trial; 3. Other patients who are considered unsuitable for this study (such as pregnancy, high blood pressure, heart disease, etc., who are not suitable for colonoscopy due to physical condition).

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;ACC;Kappa;

Countries

China

Contacts

Public ContactJianping Wang

The Sixth Affiliated Hospital, Sun Yat-sen University

wangjianpinggz@126.com+86 13808874808

Outcome results

None listed

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