Hepatocellular CarcinomaNCT03227510
MicroRNAs as Diagnostic Biomarkers in Hepatocellular Carcinoma Among Somali Patients
An observational study of Hepatocellular Carcinoma, run by People's Friendship University of Russia.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide. Although, current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI, CT-scan and laboratory analyses tests for serum tumor… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Sep 2019
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be carried out on 126 subjects who will be admitting from the outpatient clinic of Dufle Specialist Hospital Mogadishu, Somalia. They will be classified into 3 groups: Group I: It will include 63 HCC subjects. Group II: It will include 31 chronic liver disease patients. Group III: It will include 32 healthy volunteer subjects
Who may be able to join
- Confirmed diagnosis of HCC patients through history taking and physical Examination, AFP and ultrasonography (> 5cm in size).
- Chronic liver disease patients with history of liver disease rather than HCC such as cirrhosis, chronic viral hepatitis, non-alcoholic liver disease (NALD).
- Healthy volunteers with no history of liver problems.
- Informed consent from all participants before enrollment in the study.
Who cannot join
- HCC less than 5 cm in size during ultrasound examinations
- Extrahepatic disease, other primary tumour
- Inability to provide informed consent or who refused to draw off blood.
Trial locations and contacts
No sites are listed yet.
Aleksandr A Abramov contact
About this study
Official title: Circulating MicroRNAs as Biomarkers in Hepatocellular Carcinoma Among Somali Patients
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide. Although, current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI, CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP) which characterized by very low of sensitivity in the detection of HCC. Last two decades, scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood.
MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and to predict prognosis. A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently, MicroRNAs have a role in the development of HCC, but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC.
The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients and health volunteers and those HCC patients and To determine the clinical utility of MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein the current marker of (HCC).
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide. According the burden of cancer in economically developing countries is increasing in a result of population aging and growth in addition to increasing the adaptation of cancer-related lifestyle choices such as physical inactivates, smoking and western diets. Liver cancer in women are seventh most common diagnosed cancer and sixth most cause of cancer death while in men are fifth diagnosed cancer and second cause of cancer death. In 2008 liver cancer new cases were estimated 748,300 and death cases were 695,900 occurred in worldwide. Viral hepatitis infections, alcohol, fungal toxins (aflatoxins), food additives, toxins produced industrial chemicals and water and air pollutants are the major factors of primary liver cancer.
Although, current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI, CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP) which characterized by very low of sensitivity in the detection of HCC. Last two decades, scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood.
MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and to predict prognosis. A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently, MicroRNAs have a role in the development of HCC, but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC.
Purpose:
- To recognize serum microRNAs as a diagnosis or prediction biomarker for Hepatocellular carcinoma.
- To correlate with the expression level of microRNAs between HCC patients , chronic liver disease and health volunteer subjects.
- To determine the clinical utility of MicroRNAs as a diagnostic maker of Hepatocellular carcinoma comparing with alpha fetoprotein the current marker of (HCC).
Methods Study design: This is observational study (Case Control Study). A total of 126 subjects aged over 18 years old; that divided into three groups will be enrolled in this study in Dufle Specialist Hospital; these groups are HCC group, Chronic liver disease group and health volunteer group. The diagnosed criteria of HCC group are ultrasound which its nodules more than 5cm, liver function tests, viral markers and AFP. The other groups (chronic liver disease and health) the diagnoses will be based on laboratory such as (liver function tests, viral markers, AFP, complete blood count (CBC), Kidney functions and others) the clinical and laboratory analysis data will be collected perceptively The blood samples will be collected at one time, after that the blood samples will be separated using Serum-separating tubes and then centrifuges to get the serum and will be stored in -20°C before transferred from Somalia to Russia.
Viral marker Hepatitis B surface antigen (HBsAg) and antibody to HCV (anti-HCV) will be checked using commercially available enzyme linked immunosorbent assay kits for every subject of these three groups.
The expression of MicroRNAs will be detected by quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) with human TaqMan MicroRNA Assay Kits (Applied Biosystems) of these groups either HCC group , Chronic liver disease and healthy volunteers. The investigators will define the groups of HCC, Chronic liver disease and healthy volunteers with high or low expression based on the median expression value of each microRNA.
All statistical analyses will be carried out with Statistical Package for the Social Sciences (SPSS) version 20. MicroRNAs expressions among different group (HCC, Chronic liver diseases, and healthy volunteers) will be analyzed by SPSS.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma , MicroRNAs, Somalia
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCC Cases (Group 1) | This group will include 63 subjects and the diagnoses will be based on clinical examination, laboratory tests such as (Liver Function tests, Alpha-fetoprotein , Ultrasound, and biopsy in some cases if possible (Depends on the patients and their financial issues). | |
| Chronic Liver Diseases (group 2) | This group will be including 31 patients, and the diagnoses will be based on laboratory such as (liver function tests, viral markers, AFP,) and by ultrasound findings (shrunken liver, coarse echo-pattern, attenuated hepatic vein and finding nodular surface) | |
| Healthy Volunteer (group 3) | It will include 32 subjects that serve as control group. These all patients and control groups will be subject the following parameters: Biochemical tests such as (Liver function tests, viral markers, serum AFP, CBC, Kidney functions and others) and circulating MicroRNAs levels of all these subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNAs and its Correlation to Development and prediction of HCC
Circulating MicroRNAs levels in serum samples from HCC, Chronic liver diseases and health volunteers Somali subjects.
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startNov 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- People's Friendship University of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdulkadir Hassan, People's Friendship University of Russia
- Investigators
- Pavel P Ogurtsov, MD, Study chair, People's Friendship University of RussiaMohamed A Hassan, Principal investigator, RUDN University, Abrar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227510
- Sponsor's protocol ID
- 1072178049
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating MicroRNAs as Biomarkers in Hepatocellular Carcinoma Among Somali Patients
- ClinicalTrials.gov ID
- NCT03227510
- Acronym / sponsor ID
- 1072178049
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma , MicroRNAs, Somalia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- People's Friendship University of RussiaUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Jul 2017 (actual)
- 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.
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide. Although, current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI, CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP) which characterized by very low of sensitivity in the detection of HCC. Last two decades, scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood.
MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and to predict prognosis. A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently, MicroRNAs have a role in the development of HCC, but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC.
The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients and health volunteers and those HCC patients and To determine the clinical utility of MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein the current marker of (HCC).
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide. According the burden of cancer in economically developing countries is increasing in a result of population aging and growth in addition to increasing the adaptation of cancer-related lifestyle choices such as physical inactivates, smoking and western diets. Liver cancer in women are seventh most common diagnosed cancer and sixth most cause of cancer death while in men are fifth diagnosed cancer and second cause of cancer death. In 2008 liver cancer new cases were estimated 748,300 and death cases were 695,900 occurred in worldwide. Viral hepatitis infections, alcohol, fungal toxins (aflatoxins), food additives, toxins produced industrial chemicals and water and air pollutants are the major factors of primary liver cancer.
Although, current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI, CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP) which characterized by very low of sensitivity in the detection of HCC. Last two decades, scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood.
MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and to predict prognosis. A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently, MicroRNAs have a role in the development of HCC, but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC.
Purpose:
- To recognize serum microRNAs as a diagnosis or prediction biomarker for Hepatocellular carcinoma.
- To correlate with the expression level of microRNAs between HCC patients , chronic liver disease and health volunteer subjects.
- To determine the clinical utility of MicroRNAs as a diagnostic maker of Hepatocellular carcinoma comparing with alpha fetoprotein the current marker of (HCC).
Methods Study design: This is observational study (Case Control Study). A total of 126 subjects aged over 18 years old; that divided into three groups will be enrolled in this study in Dufle Specialist Hospital; these groups are HCC group, Chronic liver disease group and health volunteer group. The diagnosed criteria of HCC group are ultrasound which its nodules more than 5cm, liver function tests, viral markers and AFP. The other groups (chronic liver disease and health) the diagnoses will be based on laboratory such as (liver function tests, viral markers, AFP, complete blood count (CBC), Kidney functions and others) the clinical and laboratory analysis data will be collected perceptively The blood samples will be collected at one time, after that the blood samples will be separated using Serum-separating tubes and then centrifuges to get the serum and will be stored in -20°C before transferred from Somalia to Russia.
Viral marker Hepatitis B surface antigen (HBsAg) and antibody to HCV (anti-HCV) will be checked using commercially available enzyme linked immunosorbent assay kits for every subject of these three groups.
The expression of MicroRNAs will be detected by quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) with human TaqMan MicroRNA Assay Kits (Applied Biosystems) of these groups either HCC group , Chronic liver disease and healthy volunteers. The investigators will define the groups of HCC, Chronic liver disease and healthy volunteers with high or low expression based on the median expression value of each microRNA.
All statistical analyses will be carried out with Statistical Package for the Social Sciences (SPSS) version 20. MicroRNAs expressions among different group (HCC, Chronic liver diseases, and healthy volunteers) will be analyzed by SPSS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCC Cases (Group 1) | – | –This group will include 63 subjects and the diagnoses will be based on clinical examination, laboratory tests such as (Liver Function tests, Alpha-fetoprotein , Ultrasound, and biopsy in some cases if possible (Depends on the patients and their financial issues). |
| Chronic Liver Diseases (group 2) | – | –This group will be including 31 patients, and the diagnoses will be based on laboratory such as (liver function tests, viral markers, AFP,) and by ultrasound findings (shrunken liver, coarse echo-pattern, attenuated hepatic vein and finding nodular surface) |
| Healthy Volunteer (group 3) | – | –It will include 32 subjects that serve as control group. These all patients and control groups will be subject the following parameters: Biochemical tests such as (Liver function tests, viral markers, serum AFP, CBC, Kidney functions and others) and circulating MicroRNAs levels of all these subjects. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be carried out on 126 subjects who will be admitting from the outpatient clinic of Dufle Specialist Hospital Mogadishu, Somalia. They will be classified into 3 groups: Group I: It will include 63 HCC subjects. Group II: It will include 31 chronic liver disease patients. Group III: It will include 32 healthy volunteer subjects
Key inclusion criteria (4 listed)
- Confirmed diagnosis of HCC patients through history taking and physical Examination, AFP and ultrasonography (> 5cm in size).
- Chronic liver disease patients with history of liver disease rather than HCC such as cirrhosis, chronic viral hepatitis, non-alcoholic liver disease (NALD).
- Healthy volunteers with no history of liver problems.
- Informed consent from all participants before enrollment in the study.
Key exclusion criteria (3 listed)
- HCC less than 5 cm in size during ultrasound examinations
- Extrahepatic disease, other primary tumour
- Inability to provide informed consent or who refused to draw off blood.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MicroRNAs and its Correlation to Development and prediction of HCC
Time frame: 6 months to 1 year
Circulating MicroRNAs levels in serum samples from HCC, Chronic liver diseases and health volunteers Somali subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Aleksandr A Abramov contact
Pavel P Ogurtsov, MD study chair
People's Friendship University of Russia
Mohamed A Hassan principal investigator
RUDN University, Abrar University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by People's Friendship University of Russia.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Hassan (+79998499389, kadlesom@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MicroRNAs and its Correlation to Development and prediction of HCC (time frame: 6 months to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2017.