CirrhosisNCT02131831
Telomeres Parameters in Cirrhosis
An observational study of Cirrhosis, run by Meir Medical Center at 1 site in Israel.
Trial summary
There are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, The aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with cirrhosis
Who may be able to join
- cirrhotic patients from different etiologies
Who cannot join
- decompensated cirrhosis (Child C)
- age under 18 years
- any known malignancy, including hepatocellular carcinoma
- patient that are unable to sign for informed consent
Trial locations and contacts
1 site in 1 country.
Ido Laish, MD contact
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Ido Laish, MD, ido.laish@gmail.com
About this study
There are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, The aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in cirrhosis from different etiologies.
- Conditions
- Cirrhosis
- Keywords
- telomere, telomerase, cirrhosis
- Medical subject headings
- Fibrosis
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 |
|---|---|---|
| cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
telomerase activity
number of copies of telomerase in peripheral blood lymphocytes, as determined by FISH
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ido laish, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131831
- Sponsor's protocol ID
- IDO 123 TRX
- Status last verified
- Sep 2014
- First submitted
- 26 Apr 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telomeres Parameters in Cirrhosis
- ClinicalTrials.gov ID
- NCT02131831
- Acronym / sponsor ID
- IDO 123 TRX
- Conditions
- Cirrhosis
- Keywords
- telomere, telomerase, cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 May 2014 (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.
There are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, The aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in cirrhosis from different etiologies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cirrhosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cirrhosis
Key inclusion criteria (1 listed)
- cirrhotic patients from different etiologies
Key exclusion criteria (4 listed)
- decompensated cirrhosis (Child C)
- age under 18 years
- any known malignancy, including hepatocellular carcinoma
- patient that are unable to sign for informed consent
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
telomerase activity
Time frame: baseline
number of copies of telomerase in peripheral blood lymphocytes, as determined by FISH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
Ido Laish, MD contact
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 Cirrhosis, run by Meir Medical Center at 1 site in Israel.
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 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 16 Sep 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ido Laish, MD (ido.laish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
telomerase activity (time frame: baseline). 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 16 Sep 2014.