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Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm (NWC)

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ClinicalTrials.gov Identifier: NCT01657773
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Ming-Hua Zheng, Wenzhou Medical University

Tracking Information
First Submitted Date July 29, 2012
First Posted Date August 6, 2012
Last Update Posted Date August 6, 2012
Study Start Date April 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2012)
  • Ultrasound examination [ Time Frame: Up to 10 months ]
    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.
  • Colonoscopy examination [ Time Frame: Up to 10 months ]
    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.
  • Statistical analysis [ Time Frame: Up to 07 months ]
    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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 3, 2012)
  • Patients' baseline characteristics [ Time Frame: Up to 10 months ]
    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.
  • Laboratory Assay and Measurement [ Time Frame: Up to 10 months ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm
Official Title Study of the Prevalence of Colorectal Cancer in Patients With Nonalcoholic Fatty Liver Disease.
Brief Summary 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.
Detailed Description

As one of the most common cancer worldwide, colorectal cancer (CRC) is a major cause of cancer death in Asian countries. And during the past three decades, the incidence of CRC has been increasing rapidly in china. Many studies supported that cigarette smoking, obesity and insulin resistance were associated with CRC. In recent years, metabolic syndrome (MetS) - Including glucose tolerance, dyslipidemia, obesity, hypertension and chronic inflammation - and its individual components have been proven to be the risk for colorectal neoplasm. Colonoscopy is the most accurate technique for diagnosis, surveillance and exclusion of colorectal neoplasm for high-risk CRC groups. Therefore, improved risk stratification knowledge of the target population is necessary to improve CRC patients' prognosis.

Nonalcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide and cause a wide spectrum of liver damage, such as steatohepatitis, cirrhosis, even end-stage liver disease and hepatocellular carcinoma. NAFLD has been found to be associated with obesity, insulin resistance, hypertension and dyslipidemia, and is considered as a liver manifestation of MetS. Although it has been also well established that MetS and its individual components are risk factors for colorectal neoplasm, as above, there is paucity of research looking at the relation between NAFLD and CRC. Therefore, the investigators aimed to investigate the prevalence of CRC in patients with NAFLD and evaluate whether NAFLD is an independent risk factor for CRC.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population consisted entirely of outpatients. Patients were offered to perform colonoscopy for CRC screening according to the American College of Gastroenterology recommendations. Based on blood tests and abdomen B ultrasonography, patients without NAFLD were regarded as healthy controls and those with NAFLD constituted the community NAFLD cohort. Patients were included only if they had colonoscopy and conventional inspections (blood routine, liver function test and abdomen B ultrasonography). Among them who with history of colorectal cancers or polyps, other extraintestinal malignancies and contraindications to colonoscopy were excluded. Besides, we excluded patients who had viral hepatitis, cirrhosis, liver cancer or other liver disease.Patients who drank more than 20g alcohol per day were also excluded.
Condition
  • Colorectal Neoplasms
  • Nonalcoholic Fatty Liver Disease
Intervention Other: Ultrasound examination and Colonoscopy examination
Study Groups/Cohorts
  • colorectal cancer, without nonalcoholic fatty liver disease
    Patients were performed colonoscopy examination for colorectal cancer and who had been foud colorectal cancer proven by biopsy.Then the colorectal cancer patients who had not been diagnosed with nonalcoholic fatty liver disease was based on blood tests and abdomen ultrasound examination.
    Intervention: Other: Ultrasound examination and Colonoscopy examination
  • colorectal cancer, with nonalcoholic fatty liver disease
    Patients were performed colonoscopy examination for colorectal cancer and who had been foud colorectal cancer proven by biopsy.Then the colorectal cancer patients who had been diagnosed with nonalcoholic fatty liver disease was based on blood tests and abdomen ultrasound examination ultrasonography.
    Intervention: Other: Ultrasound examination and Colonoscopy examination
Publications * Lin XF, Shi KQ, You J, Liu WY, Luo YW, Wu FL, Chen YP, Wong DK, Yuen MF, Zheng MH. Increased risk of colorectal malignant neoplasm in patients with nonalcoholic fatty liver disease: a large study. Mol Biol Rep. 2014 May;41(5):2989-97. doi: 10.1007/s11033-014-3157-y. Epub 2014 Jan 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 3, 2012)
2315
Original Actual Enrollment Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01657773
Other Study ID Numbers wenzhouMC 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ming-Hua Zheng, Wenzhou Medical University
Study Sponsor Wenzhou Medical University
Collaborators Not Provided
Investigators
Study Chair: MingHua Zheng, Medical Master First Affiliated Hospital of Wenzhou Medical College
Principal Investigator: XianFeng Lin, Medical undergraduate Wenzhou Medical University
Principal Investigator: KeQing Shi, Medical Master First Affiliated Hospital of Wenzhou Medical College
Principal Investigator: WenYue Liu, Medical undergraduate First Affiliated Hospital of Wenzhou Medical College
PRS Account Wenzhou Medical University
Verification Date August 2012