MicroRNA Expression Profile in Human VitreousNCT01462734
MicroRNA Expression in Human Blood Serum and Vitreous Body
An observational study of MicroRNA Expression Profile in Human Vitreous, run by Kyorin University at 1 site in Japan.
Trial summary
MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of macula hole patients which is suggested to be similar to that of healthy patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- MicroRNA Expression Profile in Human Vitreous
- What is being tested?
- human vitreous and blood serum sampling, PCR
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2011to Dec 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female pateints undergoing vitrectomy for macula hole without previous ocular or systemic disease
Who may be able to join
- Female macula hole patients without previous ocular or systemic disease.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kyorin University School Of Medicine
Tokyo, Mitakasi Sinkawa6-20-2, 181-8611
About this study
MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of macula hole patients which is suggested to be similar to that of healthy patients.
- Being tested
- human vitreous and blood serum sampling, PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human vitreous and blood serum sampling, PCRProcedure or surgery
1ml of human vitreous and 3ml of human blood serum
| Study group | Role | What they receive |
|---|---|---|
| human vitreous, human blood serum, PCR | Vitreous and bloodserum samples from macula hole patients without previous ocular or systemic disease Receives: Procedure: human vitreous and blood serum sampling, PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA expression profile in human vitreous investigated by PCR
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroRNA Expression Profile in Human VitreousStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazunari Hirota, Kyorin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462734
- Sponsor's protocol ID
- No. 461
- Status last verified
- Mar 2015
- First submitted
- 26 Oct 2011
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Expression in Human Blood Serum and Vitreous Body
- ClinicalTrials.gov ID
- NCT01462734
- Acronym / sponsor ID
- No. 461
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- First posted
- 31 Oct 2011 (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.
MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of macula hole patients which is suggested to be similar to that of healthy patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human vitreous, human blood serum, PCR | – | Procedure: human vitreous and blood serum sampling, PCRVitreous and bloodserum samples from macula hole patients without previous ocular or systemic disease |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female pateints undergoing vitrectomy for macula hole without previous ocular or systemic disease
Key inclusion criteria (1 listed)
- Female macula hole patients without previous ocular or systemic disease.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| human vitreous and blood serum sampling, PCR1ml of human vitreous and 3ml of human blood serum | Procedure or surgery | human vitreous, human blood serum, PCR |
Primary outcome
MicroRNA expression profile in human vitreous investigated by PCR
Time frame: 1month
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 1 Apr 2015.
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.
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 MicroRNA Expression Profile in Human Vitreous, run by Kyorin University at 1 site in Japan.
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 0 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 1 Apr 2015. 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 Japan. 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?
MicroRNA expression profile in human vitreous investigated by PCR (time frame: 1month). 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 1 Apr 2015.