Colorectal NeoplasmsNWCNCT01657773
Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm
An observational study of Colorectal Neoplasms and Nonalcoholic Fatty Liver Disease, run by Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Nonalcoholic Fatty Liver Disease
- What is being tested?
- Ultrasound examination and Colonoscopy examination
- How many people
- 2,315 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patients had colonoscopy and
- Patients had conventional inspections(blood routine, liver function test and abdomen B ultrasonography)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Prevalence of Colorectal Cancer in Patients With Nonalcoholic Fatty Liver Disease.
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.
Read the 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.
- Being tested
- Ultrasound examination and Colonoscopy examination
- Medical subject headings
- Colorectal Neoplasms, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination and Colonoscopy examinationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Ultrasound examination and Colonoscopy examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 months
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.
Measured: Up to 10 months
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.
Measured: Up to 07 months
Secondary outcomes (2)
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.
Measured: Up to 10 months
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.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Hua Zheng, Wenzhou Medical University
- Investigators
- MingHua Zheng, Medical Master, Study chair, First Affiliated Hospital of Wenzhou Medical CollegeXianFeng Lin, Medical undergraduate, Principal investigator, Wenzhou Medical UniversityKeQing Shi, Medical Master, Principal investigator, First Affiliated Hospital of Wenzhou Medical CollegeWenYue Liu, Medical undergraduate, Principal investigator, First Affiliated Hospital of Wenzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657773
- Sponsor's protocol ID
- wenzhouMC 001
- Acronym
- NWC
- Status last verified
- Aug 2012
- First submitted
- 29 Jul 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24449368
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Colorectal Cancer in Patients With Nonalcoholic Fatty Liver Disease.
- ClinicalTrials.gov ID
- NCT01657773
- Acronym / sponsor ID
- NWC / wenzhouMC 001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,315 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer, without nonalcoholic fatty liver disease | – | Other: Ultrasound examination and Colonoscopy examinationPatients 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. |
| colorectal cancer, with nonalcoholic fatty liver disease | – | Other: Ultrasound examination and Colonoscopy examinationPatients 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients had colonoscopy and
- Patients had conventional inspections(blood routine, liver function test and abdomen B ultrasonography)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound examination and Colonoscopy examination | Other | colorectal cancer, with nonalcoholic fatty liver disease, colorectal cancer, without nonalcoholic fatty liver disease |
Primary outcome
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.
2 secondary outcomes
Patients' baseline characteristics
Time frame: Up to 10 months
Laboratory Assay and Measurement
Time frame: Up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 24449368Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MingHua Zheng, Medical Master study chair
First Affiliated Hospital of Wenzhou Medical College
XianFeng Lin, Medical undergraduate principal investigator
Wenzhou Medical University
KeQing Shi, Medical Master principal investigator
First Affiliated Hospital of Wenzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Nonalcoholic Fatty Liver Disease, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound examination (time frame: Up to 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01657773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.