Non-Alcoholic Fatty Liver DiseaseNCT04574557
Micro RNA Levels in NAFLD
An observational study of Non-Alcoholic Fatty Liver Disease, run by Assiut University.
Trial summary
Epidemiological study of NAFLD, NASH patients. Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis. - Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- micro RNA
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 15 Nov 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This is a hospital-based study will carried out prospectively in Tropical Medicine and Gastroenterology Department, Al-Rajhi Liver Hospital, Assiut University. Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group cases and control). cases : 40 patients of NAFLD patients with the previus eligibility criteria A control group : of 40 healthy age and sex-matched subjects with normal liver enzymes and abdominal ultrasonography findings
Who may be able to join
- Age 18 years or older
- Elevated aminotransferases
- Ultrasonographic presence of hyper echogenic liver
- fibroscan with a diagnosis of non-alcoholic fatty liver disease with fibrosis (NASH) without cirrhosis done no more than 6 months before the study.
Who cannot join
- A history of any level of alcohol consumption
- Any other form of chronic liver disease
- Use of any medications thought to cause or affect NAFLD
- Acute or chronic infection
- History of cancer
- Chronic kidney diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hepatic Micro RNA Expression In Non Alcoholic Fatty Liver Disease
- Epidemiological study of NAFLD, NASH patients.
- Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis. - Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is defined as the presence of hepatic steatosis (>5%-10% of hepatocytes are fatty) in people without history of excessive alcohol consumption (>21 drinks/week in men and > 14drinks/week in women) and other disease etiologies that result in fatty liver.
The presence of coexisting risk factors such as diabetes, metabolic syndrome, and obesity increases the risk of NAFLD. As a consequence of obesity pandemic and type 2 diabetes, an increased number of patients with NASH-the most severe form of NAFLD-is expected in the near future.
According to the latest epidemiological studies, the prevalence of NAFLD is approximately 25% worldwide.
In developed countries such as the United States, the prevalence of NAFLD is 30%. In developing countries such as China, the prevalence has reached up to 32.9%.
NAFLD comprises a spectrum of pathological conditions, Including simple steatosis (NAFL), nonalcoholic steatohepatitis (NASH), fibrosis, cirrhosis and hepatocellular carcinoma (HCC).
Studies have shown that approximately one-sixth of NAFL patients progress to NASH, and 20% of NASH patients can develop cirrhosis.
The traditional view suggests that HCC formation is a multi-stage process, involving inflammation, fibrosis and cirrhosis. However, recent research found that NASH can progress to HCC without fibrosis and cirrhosis.
NAFLD patients are often associated with higher risk of developing both cardiovascular disease and type 2diabetes, therefore early diagnosis of NAFLD and intervention would greatly benefit the patient by preventing the progression of major hepatic and extra hepatic manifestations.
In patients with NAFLD, the most important factor is the assessment of fibrosis severity and monitoring fibrosis progression. Most patients remain asymptomatic until their liver functionis compromised.
Thus, the identification of the presence and severity of liver fibrosis remains a clinical challenge.
Therefore, early predictors need to be investigated.
Multiple factors are involved in NAFLD development, including lipotoxicity, insulin resistance, endoplasmic reticulum stress, adipose tissue, gut microbiota, and genetics [9].
Our understanding of the pathogenesis of this disease remains limited because of its broad range and complexity.
Liver biopsy is the current gold standard in diagnosis and prognosis; nevertheless, it is an expensive and invasive procedure with high sampling error and risk of complications including pain bleeding; and, in very rare cases, death.
A biomarker is a patient characteristic assessed as an indicator of a normal or a pathologic process or of a biological response to treatment.
Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate.
Circulating extracellular vesicles (exosomes and ectosomes) contain various cellular molecules such as proteins, mRNA, miRNAs, and DNA can serve as biomarkers in NAFLD and NASH.
MicroRNAs (miRNAs) are short, non-coding single stranded RNAs strand of 20-25 nucleotides. miRNAs play complicated and important roles in regulating the expression of downstream genes .
MiRNAs contribute to the pathogenesis of NAFLD/NASH at various levels of disease development and progression and probably are the most extensively studied epigenetic modifications in NAFLD .
miR-122 is the most abundant miRNA in human liver, representing more than 70% of the total liver miRNA pool.
During hepatocytes maturation, miR-122 stimulates the expression of 24 hepatocytes-specific genes, including hepatocyte nuclear factor 6 (HNF6) [13], and in liver regeneration it has been reported to regulate hepatocytes proliferation and differentiation, recapitulating the developmental processes.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- micro RNA
- Keywords
- micro RNA
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro RNADiagnostic test
miRNA was isolated from serum using a miRNeasy Mini Kit (Qiagen, Cat; 217004)cDNA was isolated from obtained miRNA samples using a miScript Reverse Transcription Kit (Qiagen, Cat; 218060) Quantitative Real-Time PCR (qPCR) will be done using (miScript SYBR Green PCR Kit Qiagen Cat. No: 218073)The qPCR assays were performed in duplicate The relative expressions of Three miRNAs were selected for RT-PCR validation Two were selected from over-expressed miRNAs (miR-34a, miR-146b), one from under-expressed miRNAs (miR-122) were analyzed using the standard 2-ΔΔCT method. These miRNAs were selected due to their pathophysiological relation with NASH.
Predicted gene targets of all differentially expressed miRNAs will be identified. Genes with functions that are potentially relevant to the pathogenesis of NASH and gene targets that are commonly studied e.g. lipogenesis (e.g. FAS), inflammation (c-JUN kinase) will be included in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis.
Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Mahmoud Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574557
- Sponsor's protocol ID
- micro RNA in NAFLD
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dodds WJ, Hogan WJ, Miller WN. Reflux esophagitis. Am J Dig Dis. 1976 Jan;21(1):49-67. doi: 10.1007/BF01074140. No abstract available.
PubMed 3966Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365Cotter TG, Rinella M. Nonalcoholic Fatty Liver Disease 2020: The State of the Disease. Gastroenterology. 2020 May;158(7):1851-1864. doi: 10.1053/j.gastro.2020.01.052. Epub 2020 Feb 13.
PubMed 32061595Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
PubMed 32012320Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.
PubMed 16012941Febbraio MA, Reibe S, Shalapour S, Ooi GJ, Watt MJ, Karin M. Preclinical Models for Studying NASH-Driven HCC: How Useful Are They? Cell Metab. 2019 Jan 8;29(1):18-26. doi: 10.1016/j.cmet.2018.10.012. Epub 2018 Nov 15.
PubMed 30449681Baffy G, Brunt EM, Caldwell SH. Hepatocellular carcinoma in non-alcoholic fatty liver disease: an emerging menace. J Hepatol. 2012 Jun;56(6):1384-91. doi: 10.1016/j.jhep.2011.10.027. Epub 2012 Feb 9.
PubMed 22326465Anstee QM, Targher G, Day CP. Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis. Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):330-44. doi: 10.1038/nrgastro.2013.41. Epub 2013 Mar 19.
PubMed 23507799Baranova A, Younossi ZM. The future is around the corner: Noninvasive diagnosis of progressive nonalcoholic steatohepatitis. Hepatology. 2008 Feb;47(2):373-5. doi: 10.1002/hep.22140. No abstract available.
PubMed 18220279Than NN, Newsome PN. A concise review of non-alcoholic fatty liver disease. Atherosclerosis. 2015 Mar;239(1):192-202. doi: 10.1016/j.atherosclerosis.2015.01.001. Epub 2015 Jan 13.
PubMed 25617860Malhi H. Emerging role of extracellular vesicles in liver diseases. Am J Physiol Gastrointest Liver Physiol. 2019 Nov 1;317(5):G739-G749. doi: 10.1152/ajpgi.00183.2019. Epub 2019 Sep 23.
PubMed 31545919Xiao G, Zhu S, Xiao X, Yan L, Yang J, Wu G. Comparison of laboratory tests, ultrasound, or magnetic resonance elastography to detect fibrosis in patients with nonalcoholic fatty liver disease: A meta-analysis. Hepatology. 2017 Nov;66(5):1486-1501. doi: 10.1002/hep.29302. Epub 2017 Sep 26.
PubMed 28586172Pu K, Wang Y, Bai S, Wei H, Zhou Y, Fan J, Qiao L. Diagnostic accuracy of controlled attenuation parameter (CAP) as a non-invasive test for steatosis in suspected non-alcoholic fatty liver disease: a systematic review and meta-analysis. BMC Gastroenterol. 2019 Apr 8;19(1):51. doi: 10.1186/s12876-019-0961-9.
PubMed 30961539
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Micro RNA Expression In Non Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04574557
- Acronym / sponsor ID
- micro RNA in NAFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- micro RNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
- Epidemiological study of NAFLD, NASH patients.
- Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis. - Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is defined as the presence of hepatic steatosis (>5%-10% of hepatocytes are fatty) in people without history of excessive alcohol consumption (>21 drinks/week in men and > 14drinks/week in women) and other disease etiologies that result in fatty liver.
The presence of coexisting risk factors such as diabetes, metabolic syndrome, and obesity increases the risk of NAFLD. As a consequence of obesity pandemic and type 2 diabetes, an increased number of patients with NASH-the most severe form of NAFLD-is expected in the near future.
According to the latest epidemiological studies, the prevalence of NAFLD is approximately 25% worldwide.
In developed countries such as the United States, the prevalence of NAFLD is 30%. In developing countries such as China, the prevalence has reached up to 32.9%.
NAFLD comprises a spectrum of pathological conditions, Including simple steatosis (NAFL), nonalcoholic steatohepatitis (NASH), fibrosis, cirrhosis and hepatocellular carcinoma (HCC).
Studies have shown that approximately one-sixth of NAFL patients progress to NASH, and 20% of NASH patients can develop cirrhosis.
The traditional view suggests that HCC formation is a multi-stage process, involving inflammation, fibrosis and cirrhosis. However, recent research found that NASH can progress to HCC without fibrosis and cirrhosis.
NAFLD patients are often associated with higher risk of developing both cardiovascular disease and type 2diabetes, therefore early diagnosis of NAFLD and intervention would greatly benefit the patient by preventing the progression of major hepatic and extra hepatic manifestations.
In patients with NAFLD, the most important factor is the assessment of fibrosis severity and monitoring fibrosis progression. Most patients remain asymptomatic until their liver functionis compromised.
Thus, the identification of the presence and severity of liver fibrosis remains a clinical challenge.
Therefore, early predictors need to be investigated.
Multiple factors are involved in NAFLD development, including lipotoxicity, insulin resistance, endoplasmic reticulum stress, adipose tissue, gut microbiota, and genetics [9].
Our understanding of the pathogenesis of this disease remains limited because of its broad range and complexity.
Liver biopsy is the current gold standard in diagnosis and prognosis; nevertheless, it is an expensive and invasive procedure with high sampling error and risk of complications including pain bleeding; and, in very rare cases, death.
A biomarker is a patient characteristic assessed as an indicator of a normal or a pathologic process or of a biological response to treatment.
Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate.
Circulating extracellular vesicles (exosomes and ectosomes) contain various cellular molecules such as proteins, mRNA, miRNAs, and DNA can serve as biomarkers in NAFLD and NASH.
MicroRNAs (miRNAs) are short, non-coding single stranded RNAs strand of 20-25 nucleotides. miRNAs play complicated and important roles in regulating the expression of downstream genes .
MiRNAs contribute to the pathogenesis of NAFLD/NASH at various levels of disease development and progression and probably are the most extensively studied epigenetic modifications in NAFLD .
miR-122 is the most abundant miRNA in human liver, representing more than 70% of the total liver miRNA pool.
During hepatocytes maturation, miR-122 stimulates the expression of 24 hepatocytes-specific genes, including hepatocyte nuclear factor 6 (HNF6) [13], and in liver regeneration it has been reported to regulate hepatocytes proliferation and differentiation, recapitulating the developmental processes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a hospital-based study will carried out prospectively in Tropical Medicine and Gastroenterology Department, Al-Rajhi Liver Hospital, Assiut University. Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group cases and control). cases : 40 patients of NAFLD patients with the previus eligibility criteria A control group : of 40 healthy age and sex-matched subjects with normal liver enzymes and abdominal ultrasonography findings
Key inclusion criteria (4 listed)
- Age 18 years or older
- Elevated aminotransferases
- Ultrasonographic presence of hyper echogenic liver
- fibroscan with a diagnosis of non-alcoholic fatty liver disease with fibrosis (NASH) without cirrhosis done no more than 6 months before the study.
Key exclusion criteria (6 listed)
- A history of any level of alcohol consumption
- Any other form of chronic liver disease
- Use of any medications thought to cause or affect NAFLD
- Acute or chronic infection
- History of cancer
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 |
|---|---|---|
| micro RNAmiRNA was isolated from serum using a miRNeasy Mini Kit (Qiagen, Cat; 217004)cDNA was isolated from obtained miRNA samples using a miScript Reverse Transcription Kit (Qiagen, Cat; 218060) Quantitative Real-Time PCR (qPCR) will be done using (miScript SYBR Green PCR Kit Qiagen Cat. No: 218073)The qPCR assays were performed in duplicate The relative expressions of Three miRNAs were selected for RT-PCR validation Two were selected from over-expressed miRNAs (miR-34a, miR-146b), one from under-expressed miRNAs (miR-122) were analyzed using the standard 2-ΔΔCT method. These miRNAs were selected due to their pathophysiological relation with NASH. Predicted gene targets of all differentially expressed miRNAs will be identified. Genes with functions that are potentially relevant to the pathogenesis of NASH and gene targets that are commonly studied e.g. lipogenesis (e.g. FAS), inflammation (c-JUN kinase) will be included in the study | Diagnostic test | – |
Primary outcome
Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis.
Time frame: baseline
Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 3966Dodds WJ, Hogan WJ, Miller WN. Reflux esophagitis. Am J Dig Dis. 1976 Jan;21(1):49-67. doi: 10.1007/BF01074140. No abstract available.
- Background: PubMed 26707365Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Background: PubMed 32061595Cotter TG, Rinella M. Nonalcoholic Fatty Liver Disease 2020: The State of the Disease. Gastroenterology. 2020 May;158(7):1851-1864. doi: 10.1053/j.gastro.2020.01.052. Epub 2020 Feb 13.
- Background: PubMed 32012320Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
- Background: PubMed 16012941Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.
- Background: PubMed 30449681Febbraio MA, Reibe S, Shalapour S, Ooi GJ, Watt MJ, Karin M. Preclinical Models for Studying NASH-Driven HCC: How Useful Are They? Cell Metab. 2019 Jan 8;29(1):18-26. doi: 10.1016/j.cmet.2018.10.012. Epub 2018 Nov 15.
- Background: PubMed 22326465Baffy G, Brunt EM, Caldwell SH. Hepatocellular carcinoma in non-alcoholic fatty liver disease: an emerging menace. J Hepatol. 2012 Jun;56(6):1384-91. doi: 10.1016/j.jhep.2011.10.027. Epub 2012 Feb 9.
- Background: PubMed 23507799Anstee QM, Targher G, Day CP. Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis. Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):330-44. doi: 10.1038/nrgastro.2013.41. Epub 2013 Mar 19.
- Background: PubMed 18220279Baranova A, Younossi ZM. The future is around the corner: Noninvasive diagnosis of progressive nonalcoholic steatohepatitis. Hepatology. 2008 Feb;47(2):373-5. doi: 10.1002/hep.22140. No abstract available.
- Background: PubMed 25617860Than NN, Newsome PN. A concise review of non-alcoholic fatty liver disease. Atherosclerosis. 2015 Mar;239(1):192-202. doi: 10.1016/j.atherosclerosis.2015.01.001. Epub 2015 Jan 13.
- Background: PubMed 31545919Malhi H. Emerging role of extracellular vesicles in liver diseases. Am J Physiol Gastrointest Liver Physiol. 2019 Nov 1;317(5):G739-G749. doi: 10.1152/ajpgi.00183.2019. Epub 2019 Sep 23.
- Background: PubMed 28586172Xiao G, Zhu S, Xiao X, Yan L, Yang J, Wu G. Comparison of laboratory tests, ultrasound, or magnetic resonance elastography to detect fibrosis in patients with nonalcoholic fatty liver disease: A meta-analysis. Hepatology. 2017 Nov;66(5):1486-1501. doi: 10.1002/hep.29302. Epub 2017 Sep 26.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Assiut University.
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 6 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 5 Oct 2020. 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 Nourhan M.Abbas, master (01027408731, nourmahmoud845@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis. (time frame: baseline). 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 NCT04574557, which also lists 13 linked publications.
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 5 Oct 2020.