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Study on the specificity and sensitivity of combined detection of blood cfDNA methylation in the diagnosis of colorectal cancer

Study on the specificity and sensitivity of combined detection of blood cfDNA methylation in the diagnosis of colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081245
Enrollment
Unknown
Registered
2024-02-27
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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:Pathological test results
Index test:Septin9 and BCAT1 gene methylation detection kit (Fluorescence PCR method)

Sponsors

Zhongshan Hospital Affiliated to Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: A. Group of suspected cases of colorectal cancer or precancerous lesions ? Clinical doctors suggest performing colonoscopy for suspected cases of colorectal cancer or precancerous lesions. ? No history of malignant tumors, no history of radiation or chemotherapy treatment, all females are non pregnant. ? The sample type should be plasma sample, and the blood collection time should be before colonoscopy examination. ? The sample information is complete and the participants voluntarily participate in the experiment. B. Other malignant tumor groups other than colorectal cancer ? Cases of other malignant tumors diagnosed as non colorectal cancer. ? The sample type should be plasma samples, and the blood collection time should be before various cancer treatments. ? Complete sample information, voluntary participants in the trial C. Patients with no space occupying lesions in the intestine or healthy individuals ? Under colonoscopy, there were no other abnormalities except for hemorrhoids. ? Complete sample information, voluntary participants in the trial D. Cases after surgical treatment for colorectal cancer ? Preoperative samples were collected using the Septin9 and BCAT1 gene methylation combined detection kit (fluorescence PCR method) developed by Xiamen Tengji Medical Technology Co., Ltd. to detect positive cases. ? The postoperative sampling time should be scientifically set based on the development pattern of the disease and the requirements of post-treatment monitoring time. It is recommended to collect samples from patients within six months after surgery.

Exclusion criteria

Exclusion criteria: ? The sample volume does not meet the demand for comparative reagents/methods used in the assessment kit. ? The researchers believe that other reasons are not suitable for participants in this trial. ? Exclude patients who have been diagnosed with colorectal polyps, colorectal cancer, or related intestinal diseases, or have a family history of CRC.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactGuoyang Wu

Zhongshan Hospital Affiliated to Xiamen University

wuguoyangmail@aliyum.com+86 136 0090 3651

Outcome results

None listed

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