Hepatocellular CarcinomaNCT02928627
Clinical Significance of Hepatic and Circulating microRNAs miR-221 and miR-222 in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the third cause of cancer-related mortality worldwide. Depending on the stage of the disease, the treatment options are surgery, liver transplantation, chemotherapy or radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Analysis of microRNA expression
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 24 Jan 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient affected by hepatocellular carcinoma undergoing curative surgical treatment
Who may be able to join
- hepatocellular carcinoma, not eligible for liver transplant undergoing surgical resection
Who cannot join
- extrahepatic disease, other primary tumour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic and Circulating microRNAs miR-221 and miR-222 Expression and Its Clinical Significance in Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the third cause of cancer-related mortality worldwide. Depending on the stage of the disease, the treatment options are surgery, liver transplantation, chemotherapy or radiotherapy.
Recently, scientific research has focused on small molecules called microRNAs which are produced by human cells and can be released in the blood. They have a role in cell proliferation and are found to be dysregulated in different types of cancer.
Read more
It has been shown that microRNAs have a role in the development of HCC but it is unknown if these molecules can be used as markers for diagnosis and survival in HCC.
In particular, microRNAs miR-221 and miR-222 are dysregulated in the tumoral tissues in about 80% of patients with HCC. This can be assessed on tissues from liver biopsies or surgical specimens, both invasive approaches. Only few studies showed the presence of microRNAs in the blood of patients with HCC but it is unknown if there is a correlation between tumoral tissue expression and circulating levels.
The aim of this study is to evaluate if these two microRNAs are expressed not only in the tumoral tissues but also in the blood from cancer patients, and in different amounts compared to circulating levels in healthy individuals. A correlation between tumoral tissue and blood levels will also be evaluated.
Should this evaluation show a strong correlation and reliability of circulating microRNAs in the diagnosis and follow up of HCC, future clinical trials targeting these microRNAs and their related pathways might benefit from this being adopted as conventional practice instead of the need of assessing tissue levels from liver biopsies.
The results of this pilot study will bring preliminary results as a first step for future analysis on a larger cohort of patients.
Read the detailed description
- Background \& Rationale Hepatocellular carcinoma (HCC) is the sixth most prevalent cancer worldwide, and is the third cause of cancer-related mortality. Surgical resection remains the best curative treatment option for patients with clinical Barcelona-Clinic Liver Cancer (BCLC) stage A disease and it has shown benefits even in the more advanced stage B with multifocal disease or limited vascular invasion. Despite curative treatments offering a 5-year survival rate of 50-70%, recurrence rates at 5 years after surgery are as high as 70%. Therefore, more efforts are needed in order to identify prognostic factors for recurrence and survival. MicroRNAs are a class of small non-coding RNAs molecules, which act as key regulators of cell proliferation, differentiation, apoptosis and embryonic development, finely tuning gene expression at post-transcriptional level. They act as oncogenes or tumor suppressors depending on the target genes. In HCC, it has been reported the upregulation or downregulation of a few cluster of microRNAs, with a subsequent activation of molecular networks such as b-catenin, Ras, TGF-b, JAK/STAT and creation of a highly controlled feedback mechanism. Their involvement in carcinogenesis represents an important area of investigation for the development of their clinical applications: diagnostics, monitoring and therapeutics. MicroRNA profiles can distinguish between normal and cancerous tissue, identify tissue of origin and also discriminate different subtypes or specific oncogenic abnormalities. Indeed, microRNA mis-expression patterns are more accurate in identifying the origin of tumours that are otherwise difficult to be determined, suggesting that tumours more clearly maintain a unique tissue microRNA expression profile. MicroRNAs could also be useful as early diagnosis biomarkers for patient follow-up. In liver tumorigenesis, the role of miR-221 and miR-222 has not been completely elucidated. Previous studies showed that miR-221 was upregulated in 83% of HCC tumoral samples when compared with matched cirrhotic tissue. Increased expression of serum miR-221 was found in HCC patients compared to healthy normal controls, which was associated with the presence of other poor prognostic factors and with poorer outcomes after liver resection. The extraction of microRNAs from liver samples is limited by the ability to resecting the tumour or the possibility to perform a liver biopsy in each patient. On the contrary, a blood sample is easy to be collected and stored for analysis. At present, it has not been clearly established a correlation between the expression of miR-221 and miR-222 in the liver tissue (tumoral and non tumoral) and the circulating miR-221 and miR-222 levels. The confirmation of this correlation, would allow identifying a cutoff of circulating levels which could be used as a surrogate marker in order to include HCC patients in phase 3 trials without the need for a liver biopsy, which is often contraindicated for clinical reasons and according to guidelines. This is a pilot study to evaluate the correlation between the overexpression of miR-221 and miR-222 in paired tumoral/non tumoral liver tissue and blood samples in patients with HCC and to identify a cutoff for the circulating levels to use as a surrogate marker in clinical trials. This study therefore aims to evaluate if miR-221 and miR-222 expression in the blood correlates with tissue expression and if the circulating levels could be used as a surrogate of overexpression in the tumoral liver tissue. Should this evaluation show a strong correlation and reliability of circulating miRNAs, in the diagnosis and follow up of HCC, future clinical trials targeting these miRNAs and their related pathways might benefit from this being adopted as conventional practice instead of the need of assessing tissue levels from liver biopsies. The trial will be conducted in compliance with the principles of the Declaration of Helsinki, the principles of GCP and all (if any) applicable regulatory requirements are essential. NHS Grampian Biorepository will provide the anonymised samples to be used for this study. NHS Grampian Biorepository already has ethical approval in place for these types of studies. Research and Development approval will be sought.
- Methods Blood samples from patients with HCC and from age-matched healthy controls, stored in the National bio-repository Scotland, will be tested for circulating miR-221 and miR-222 expression by the means of Real Time Reverse Transcription Polymerase Chain Reaction (RT-qPCR). Similarly, levels of miR-221 and miR-222 will be assessed in paired cancer and healthy liver tissue form patients with HCC. Sample analysis will take place in the Institute for Health and Wellbeing Research laboratory at Robert Gordon University (RGU) - Aberdeen. Results from the analysis of samples and quantification of microRNAs via RT-qPCR will be carried out by the chief investigator along with the research team in the laboratory facilities. Samples will be analysed to assess miR-221 and miR-222 overexpression between tumoral and non tumoral liver tissue and to assess the correlation between this and circulating miR-221 and miR-222. Circulating levels will be compared to results from age-matched healthy controls. The custodian of the data generated by the study will be the Chief Investigator. Samples will be stored in the laboratory facilities at RGU and only the chief investigator and the research team will have access to. Data generated by the study will be collected in a spreadsheet which will be bespoke and held on the intranet with access restricted only to the CI and the research team. Anonymised data on computer files will be stored on password-protected databases accessible only to the study investigators. All written files will be stored in locked filling cabinets within a secure store at Robert Gordon University with the exception of consents which are stored by NHS Grampian Biorepository. The University of Aberdeen and NHS Grampian monitoring procedures will be followed. At the end of the research the samples will be stored by research team pending ethical approval for use in another project, whereas the data generated by the study will be stored on password-protected databases accessible only to the study investigators.
- Consent Process NHS Grampian Biorepository seek informed consent by patients for collection of tissue samples and blood through a dedicated research nurse and the use of a patient information sheet and a consent form which are part of the NHS Grampian Biorepository documentation. A consent will be obtained for all the samples used in this study according to the Biorepository consent process.
- Trial Flowchart
- Five frozen paired hepatic tumoral and non tumoral tissue and five frozen plasma samples obtained from patients with HCC and stored in the National Bio-Repository Scotland (HCC Group, HCC). Five voluntary age-matched healthy controls will be recruited to relate the expression of circulating miRNAs (Plasma Control Group, PCG).
- Paired frozen HCC tissue specimens and their adjacent non-cancerous normal liver will be collected in RNA Stabilisation tubes and stored at -80C until further analysis and miRNAs extraction as per protocol. The average size of the specimen will be 2 by 10 mm in diameter.
- Blood samples collected from both HCC Group and PCG (8-10ml, into BD Vacutainer K3-EDTA blood collection tubes) will be collected. All samples will be sent to Bio-Repository for further processing and then analysis and miRNAs extraction as per protocol.
- The results of miRNAs extraction from paired HCC/non-cancerous tissues will be compared and from HCC Group plasma will be compared to the matched plasma of controls (PCG Group).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Analysis of microRNA expression
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of microRNA expressionOther
sample analysis
| Study group | Role | What they receive |
|---|---|---|
| HCC Group | samples obtained from patients with HCC (hepatic tissue and blood) Receives: Other: Analysis of microRNA expression | |
| Plasma control Group (PCG) | blood samples obtained from healthy controls Receives: Other: Analysis of microRNA expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of miR-221 and mR-222 in the blood
To evaluate the presence of miR-221 and mR-222 in the blood of patients with HCC compared to age-matched healthy controls
Measured: 6 months
Secondary outcomes (1)
correlation of expression of miR-221 and miR-222 in tissue and blood samples
To evaluate the correlation between the expression of miR-221 and miR-222 in tissue and blood samples in patients with HCC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start1 Jun 2017
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Why it stopped: The project did not progress as there were no findings available for the lab analysis of microRNA expression.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Gordon University
- Responsible party
- Sponsor
- Investigators
- Fiammetta Soggiu, MD, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928627
- Sponsor's protocol ID
- 1-035-16
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Qi J, Wang J, Katayama H, Sen S, Liu SM. Circulating microRNAs (cmiRNAs) as novel potential biomarkers for hepatocellular carcinoma. Neoplasma. 2013;60(2):135-42. doi: 10.4149/neo_2013_018.
PubMed 23259781Gramantieri L, Ferracin M, Fornari F, Veronese A, Sabbioni S, Liu CG, Calin GA, Giovannini C, Ferrazzi E, Grazi GL, Croce CM, Bolondi L, Negrini M. Cyclin G1 is a target of miR-122a, a microRNA frequently down-regulated in human hepatocellular carcinoma. Cancer Res. 2007 Jul 1;67(13):6092-9. doi: 10.1158/0008-5472.CAN-06-4607.
PubMed 17616664Li J, Wang Y, Yu W, Chen J, Luo J. Expression of serum miR-221 in human hepatocellular carcinoma and its prognostic significance. Biochem Biophys Res Commun. 2011 Mar 4;406(1):70-3. doi: 10.1016/j.bbrc.2011.01.111. Epub 2011 Feb 3.
PubMed 21295551
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic and Circulating microRNAs miR-221 and miR-222 Expression and Its Clinical Significance in Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02928627
- Acronym / sponsor ID
- 1-035-16
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The project did not progress as there were no findings available for the lab analysis of microRNA expression.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Robert Gordon University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 10 Oct 2016 (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.
Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the third cause of cancer-related mortality worldwide. Depending on the stage of the disease, the treatment options are surgery, liver transplantation, chemotherapy or radiotherapy.
Recently, scientific research has focused on small molecules called microRNAs which are produced by human cells and can be released in the blood. They have a role in cell proliferation and are found to be dysregulated in different types of cancer.
It has been shown that microRNAs have a role in the development of HCC but it is unknown if these molecules can be used as markers for diagnosis and survival in HCC.
In particular, microRNAs miR-221 and miR-222 are dysregulated in the tumoral tissues in about 80% of patients with HCC. This can be assessed on tissues from liver biopsies or surgical specimens, both invasive approaches. Only few studies showed the presence of microRNAs in the blood of patients with HCC but it is unknown if there is a correlation between tumoral tissue expression and circulating levels.
The aim of this study is to evaluate if these two microRNAs are expressed not only in the tumoral tissues but also in the blood from cancer patients, and in different amounts compared to circulating levels in healthy individuals. A correlation between tumoral tissue and blood levels will also be evaluated.
Should this evaluation show a strong correlation and reliability of circulating microRNAs in the diagnosis and follow up of HCC, future clinical trials targeting these microRNAs and their related pathways might benefit from this being adopted as conventional practice instead of the need of assessing tissue levels from liver biopsies.
The results of this pilot study will bring preliminary results as a first step for future analysis on a larger cohort of patients.
Detailed description
- Background \& Rationale Hepatocellular carcinoma (HCC) is the sixth most prevalent cancer worldwide, and is the third cause of cancer-related mortality. Surgical resection remains the best curative treatment option for patients with clinical Barcelona-Clinic Liver Cancer (BCLC) stage A disease and it has shown benefits even in the more advanced stage B with multifocal disease or limited vascular invasion. Despite curative treatments offering a 5-year survival rate of 50-70%, recurrence rates at 5 years after surgery are as high as 70%. Therefore, more efforts are needed in order to identify prognostic factors for recurrence and survival. MicroRNAs are a class of small non-coding RNAs molecules, which act as key regulators of cell proliferation, differentiation, apoptosis and embryonic development, finely tuning gene expression at post-transcriptional level. They act as oncogenes or tumor suppressors depending on the target genes. In HCC, it has been reported the upregulation or downregulation of a few cluster of microRNAs, with a subsequent activation of molecular networks such as b-catenin, Ras, TGF-b, JAK/STAT and creation of a highly controlled feedback mechanism. Their involvement in carcinogenesis represents an important area of investigation for the development of their clinical applications: diagnostics, monitoring and therapeutics. MicroRNA profiles can distinguish between normal and cancerous tissue, identify tissue of origin and also discriminate different subtypes or specific oncogenic abnormalities. Indeed, microRNA mis-expression patterns are more accurate in identifying the origin of tumours that are otherwise difficult to be determined, suggesting that tumours more clearly maintain a unique tissue microRNA expression profile. MicroRNAs could also be useful as early diagnosis biomarkers for patient follow-up. In liver tumorigenesis, the role of miR-221 and miR-222 has not been completely elucidated. Previous studies showed that miR-221 was upregulated in 83% of HCC tumoral samples when compared with matched cirrhotic tissue. Increased expression of serum miR-221 was found in HCC patients compared to healthy normal controls, which was associated with the presence of other poor prognostic factors and with poorer outcomes after liver resection. The extraction of microRNAs from liver samples is limited by the ability to resecting the tumour or the possibility to perform a liver biopsy in each patient. On the contrary, a blood sample is easy to be collected and stored for analysis. At present, it has not been clearly established a correlation between the expression of miR-221 and miR-222 in the liver tissue (tumoral and non tumoral) and the circulating miR-221 and miR-222 levels. The confirmation of this correlation, would allow identifying a cutoff of circulating levels which could be used as a surrogate marker in order to include HCC patients in phase 3 trials without the need for a liver biopsy, which is often contraindicated for clinical reasons and according to guidelines. This is a pilot study to evaluate the correlation between the overexpression of miR-221 and miR-222 in paired tumoral/non tumoral liver tissue and blood samples in patients with HCC and to identify a cutoff for the circulating levels to use as a surrogate marker in clinical trials. This study therefore aims to evaluate if miR-221 and miR-222 expression in the blood correlates with tissue expression and if the circulating levels could be used as a surrogate of overexpression in the tumoral liver tissue. Should this evaluation show a strong correlation and reliability of circulating miRNAs, in the diagnosis and follow up of HCC, future clinical trials targeting these miRNAs and their related pathways might benefit from this being adopted as conventional practice instead of the need of assessing tissue levels from liver biopsies. The trial will be conducted in compliance with the principles of the Declaration of Helsinki, the principles of GCP and all (if any) applicable regulatory requirements are essential. NHS Grampian Biorepository will provide the anonymised samples to be used for this study. NHS Grampian Biorepository already has ethical approval in place for these types of studies. Research and Development approval will be sought.
- Methods Blood samples from patients with HCC and from age-matched healthy controls, stored in the National bio-repository Scotland, will be tested for circulating miR-221 and miR-222 expression by the means of Real Time Reverse Transcription Polymerase Chain Reaction (RT-qPCR). Similarly, levels of miR-221 and miR-222 will be assessed in paired cancer and healthy liver tissue form patients with HCC. Sample analysis will take place in the Institute for Health and Wellbeing Research laboratory at Robert Gordon University (RGU) - Aberdeen. Results from the analysis of samples and quantification of microRNAs via RT-qPCR will be carried out by the chief investigator along with the research team in the laboratory facilities. Samples will be analysed to assess miR-221 and miR-222 overexpression between tumoral and non tumoral liver tissue and to assess the correlation between this and circulating miR-221 and miR-222. Circulating levels will be compared to results from age-matched healthy controls. The custodian of the data generated by the study will be the Chief Investigator. Samples will be stored in the laboratory facilities at RGU and only the chief investigator and the research team will have access to. Data generated by the study will be collected in a spreadsheet which will be bespoke and held on the intranet with access restricted only to the CI and the research team. Anonymised data on computer files will be stored on password-protected databases accessible only to the study investigators. All written files will be stored in locked filling cabinets within a secure store at Robert Gordon University with the exception of consents which are stored by NHS Grampian Biorepository. The University of Aberdeen and NHS Grampian monitoring procedures will be followed. At the end of the research the samples will be stored by research team pending ethical approval for use in another project, whereas the data generated by the study will be stored on password-protected databases accessible only to the study investigators.
- Consent Process NHS Grampian Biorepository seek informed consent by patients for collection of tissue samples and blood through a dedicated research nurse and the use of a patient information sheet and a consent form which are part of the NHS Grampian Biorepository documentation. A consent will be obtained for all the samples used in this study according to the Biorepository consent process.
- Trial Flowchart
- Five frozen paired hepatic tumoral and non tumoral tissue and five frozen plasma samples obtained from patients with HCC and stored in the National Bio-Repository Scotland (HCC Group, HCC). Five voluntary age-matched healthy controls will be recruited to relate the expression of circulating miRNAs (Plasma Control Group, PCG).
- Paired frozen HCC tissue specimens and their adjacent non-cancerous normal liver will be collected in RNA Stabilisation tubes and stored at -80C until further analysis and miRNAs extraction as per protocol. The average size of the specimen will be 2 by 10 mm in diameter.
- Blood samples collected from both HCC Group and PCG (8-10ml, into BD Vacutainer K3-EDTA blood collection tubes) will be collected. All samples will be sent to Bio-Repository for further processing and then analysis and miRNAs extraction as per protocol.
- The results of miRNAs extraction from paired HCC/non-cancerous tissues will be compared and from HCC Group plasma will be compared to the matched plasma of controls (PCG Group).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC Group | – | Other: Analysis of microRNA expressionsamples obtained from patients with HCC (hepatic tissue and blood) |
| Plasma control Group (PCG) | – | Other: Analysis of microRNA expressionblood samples obtained from healthy controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient affected by hepatocellular carcinoma undergoing curative surgical treatment
Key inclusion criteria (1 listed)
- hepatocellular carcinoma, not eligible for liver transplant undergoing surgical resection
Key exclusion criteria (1 listed)
- extrahepatic disease, other primary tumour
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 |
|---|---|---|
| Analysis of microRNA expressionsample analysis | Other | HCC Group, Plasma control Group (PCG) |
Primary outcome
presence of miR-221 and mR-222 in the blood
Time frame: 6 months
To evaluate the presence of miR-221 and mR-222 in the blood of patients with HCC compared to age-matched healthy controls
1 secondary outcome
correlation of expression of miR-221 and miR-222 in tissue and blood samples
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The project did not progress as there were no findings available for the lab analysis of microRNA expression.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 23259781Qi J, Wang J, Katayama H, Sen S, Liu SM. Circulating microRNAs (cmiRNAs) as novel potential biomarkers for hepatocellular carcinoma. Neoplasma. 2013;60(2):135-42. doi: 10.4149/neo_2013_018.
- Background: PubMed 17616664Gramantieri L, Ferracin M, Fornari F, Veronese A, Sabbioni S, Liu CG, Calin GA, Giovannini C, Ferrazzi E, Grazi GL, Croce CM, Bolondi L, Negrini M. Cyclin G1 is a target of miR-122a, a microRNA frequently down-regulated in human hepatocellular carcinoma. Cancer Res. 2007 Jul 1;67(13):6092-9. doi: 10.1158/0008-5472.CAN-06-4607.
- Background: PubMed 21295551Li J, Wang Y, Yu W, Chen J, Luo J. Expression of serum miR-221 in human hepatocellular carcinoma and its prognostic significance. Biochem Biophys Res Commun. 2011 Mar 4;406(1):70-3. doi: 10.1016/j.bbrc.2011.01.111. Epub 2011 Feb 3.
- 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.
Fiammetta Soggiu, MD principal investigator
NHS Grampian
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 Hepatocellular Carcinoma, run by University of Aberdeen at 1 site in United Kingdom.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 May 2026. 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 United Kingdom. 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 was stopped early (reason given: The project did not progress as there were no findings available for the lab analysis of microRNA expression.). 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?
presence of miR-221 and mR-222 in the blood (time frame: 6 months). 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 NCT02928627, which also lists 3 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 11 May 2026.