miRna in HCCNCT03429530
Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma
An observational study of miRna in HCC, run by HMHamed.
Trial summary
The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- miRna in HCC
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2018to Mar 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: This study will be carried out in Al-Raghy hospital (Assiut university), in collaboration with Medical Microbiology \&Immunology Department. Eighty patients with HCV related chronic liver disease will be included. GroupI; 20 patients with chronic HCV GroupII; 20 patient with chronic HCV related liver cirrhosis GroupIII; 40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma Control group: (group IV) Sex and age matched 20 healthy blood donors will also be included as a control group
Who may be able to join
- RNA extraction and quantitative Real-Time PCR analysis
- Diagnosis of HCV will be based on detection of anti-HCV antibodies
- Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available
- Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan
Who cannot join
- HBV or autoimmune or metabolic liver disease
- serological evidence of human immunodeficiency virus (HIV) infection
- malignancy in other organs
- After intervention in treatment of hepatocellular carcinoma
About this study
The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.
Read the detailed description
Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues.
miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.
- Conditions
- miRna in HCC
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 |
|---|---|---|
| Group1 | 20 patients with chronic HCV | |
| GroupII | 20 patient with chronic HCV related liver cirrhosis | |
| GroupIII | 40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma | |
| group IV | 20 healthy blood donors will also be included as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.
cilculating miRNAs in serum samples of HCV related HCC, HCV related liver cirrhosis , chronic HCV and healthy control group
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Feb 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for miRna in HCCStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HMHamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HMHamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429530
- Sponsor's protocol ID
- miRNA in HCC
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03429530
- Acronym / sponsor ID
- miRNA in HCC
- Conditions
- miRna in HCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HMHamedUniversity, hospital or other
- Study start
- 15 Feb 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 12 Feb 2018 (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.
The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.
Detailed description
Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues.
miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –20 patients with chronic HCV |
| GroupII | – | –20 patient with chronic HCV related liver cirrhosis |
| GroupIII | – | –40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma |
| group IV | – | –20 healthy blood donors will also be included as a control group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will be carried out in Al-Raghy hospital (Assiut university), in collaboration with Medical Microbiology \&Immunology Department. Eighty patients with HCV related chronic liver disease will be included. GroupI; 20 patients with chronic HCV GroupII; 20 patient with chronic HCV related liver cirrhosis GroupIII; 40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma Control group: (group IV) Sex and age matched 20 healthy blood donors will also be included as a control group
Key inclusion criteria (4 listed)
- RNA extraction and quantitative Real-Time PCR analysis
- Diagnosis of HCV will be based on detection of anti-HCV antibodies
- Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available
- Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan
Key exclusion criteria (4 listed)
- HBV or autoimmune or metabolic liver disease
- serological evidence of human immunodeficiency virus (HIV) infection
- malignancy in other organs
- After intervention in treatment of hepatocellular carcinoma
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
the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.
Time frame: basline
cilculating miRNAs in serum samples of HCV related HCC, HCV related liver cirrhosis , chronic HCV and healthy control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of miRna in HCC, run by HMHamed.
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 4 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 12 Feb 2018. 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?
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?
the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma. (time frame: basline). 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 12 Feb 2018.