Colorectal Neoplasms Clinical Trial
— NWCOfficial title:
Study of the Prevalence of Colorectal Cancer in Patients With Nonalcoholic Fatty Liver Disease.
Verified date | August 2012 |
Source | Wenzhou Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Observational |
The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor for CRC.
Status | Completed |
Enrollment | 2315 |
Est. completion date | July 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - Patients had colonoscopy and - Patients had conventional inspections(blood routine, liver function test and abdomen B ultrasonography) Exclusion Criteria: - Patients were excluded with history of colorectal cancers or polyps, other extraintestinal malignancies and contraindications to colonoscopy. - Patients were excluded who had viral hepatitis, cirrhosis, liver cancer or other liver disease. - Patients ere excluded who drank more than 20g alcohol per day. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
China | Wenzhou Medical College | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Wenzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultrasound examination | Hepatic ultrasonography scanning was performed on all patients by experienced radiologists who were blinded to the aims of the study and clinical details of the patients. NAFLD was diagnosed by the following criterion: hepatomegaly, the echogenicity of liver parenchyma increased diffusely, and vascular blurring. | Up to 10 months | No |
Primary | Colonoscopy examination | Before performed colonoscopy examination, all patients were given 4L polyethelyne glycol lavage solution for bowel preparation. The colonoscopic features include the types, location, size, number of lesions and differentiation of neoplasm. |
Up to 10 months | No |
Primary | Statistical analysis | The Binary logistic regression analysis was applied to assay the correlation between NAFLD and CRC after adjustment for independent factors, including age, gender, smoking, and family history. | Up to 07 months | No |
Secondary | Patients' baseline characteristics | Patients' baseline characteristics were collected before colonoscopy examination. Smoking, alcohol consumption, past medical history, and family history were all recorded using a standardized questionnaire.Blood pressure (BP) was measured in rest state with a standard mercury sphygmomanometer. | Up to 10 months | No |
Secondary | Laboratory Assay and Measurement | Complete blood count, liver function, blood glucose , blood lipids, Cancer Embryo Antigen (CEA) and other related test were performed when underwent colonoscopy examination. The liver function test included alanine aminotranferase, aspartate aminotranferase, albumin, serum sodium, serum chloride, serum chloride and creatinine. Complete blood count was made up of platelet and hemoglobin (Hb). Blood lipids test contains, total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. Additionally, CEA was detected by conventional serological assays. | Up to 10 months | No |
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