Primary Sclerosing CholangitisNCT02247622
Telomere Length and Other Parameters of Telomere Dysfunction in PSC and Colitis
An observational study of Primary Sclerosing Cholangitis and Inflammatory Bowel Disease, run by Meir Medical Center at 1 site in Israel.
Trial summary
PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Sclerosing Cholangitis, Inflammatory Bowel Disease
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to Sep 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with primary sclerosing cholangitis and inflammatory bowel disease
Who may be able to join
- informed consent
- documented PSC and inflammatory bowel disease
Who cannot join
- under 18 years, above 80 y
- known active malignancy
- decompensated cirrhosis
- patients who cannot sign informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Ido Laish, MD, ido.laish@gmail.com
Ido Laish, Md
About this study
Official title: Primary Sclerosing Cholangitis Telomere Length
PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.
Read the detailed description
Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene copy number, telomere length, cells in senescence, aneuploidy and additional parameters of telomere dysfunction from peripheral blood lymphocytes of patients.
- Keywords
- telomeres, PSC
- Medical subject headings
- Cholangitis, Sclerosing, Inflammatory Bowel Diseases
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 |
|---|---|---|
| Healthy control | Not described | |
| IBD | patients with inflammatory bowel disease, study group | |
| PSC | patients with primary sclerosing cholangitis, study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length
Measured: 1.5 years
Secondary outcomes (1)
number of cells with increased telomerase RNA component (TERC) expression
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startFeb 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sclerosing CholangitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT02247622
- Sponsor's protocol ID
- 1.1
- Status last verified
- Sep 2014
- First submitted
- 10 Jul 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Laish I, Katz H, Stein A, Liberman M, Naftali T, Kitay-Cohen Y, Biron-Shental T, Konikoff FM, Amiel A. Telomere dysfunction in peripheral blood lymphocytes from patients with primary sclerosing cholangitis and inflammatory bowel disease. Dig Liver Dis. 2015 Sep;47(9):790-6. doi: 10.1016/j.dld.2015.05.002. Epub 2015 May 13.
PubMed 26048252
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Sclerosing Cholangitis Telomere Length
- ClinicalTrials.gov ID
- NCT02247622
- Acronym / sponsor ID
- 1.1
- Keywords
- telomeres, PSC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 25 Sep 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.
PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.
Detailed description
Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene copy number, telomere length, cells in senescence, aneuploidy and additional parameters of telomere dysfunction from peripheral blood lymphocytes of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | – |
| IBD | – | –patients with inflammatory bowel disease, study group |
| PSC | – | –patients with primary sclerosing cholangitis, study group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary sclerosing cholangitis and inflammatory bowel disease
Key inclusion criteria (2 listed)
- informed consent
- documented PSC and inflammatory bowel disease
Key exclusion criteria (4 listed)
- under 18 years, above 80 y
- known active malignancy
- decompensated cirrhosis
- patients who cannot sign 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
Telomere length
Time frame: 1.5 years
1 secondary outcome
number of cells with increased telomerase RNA component (TERC) expression
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Derived from this study: PubMed 26048252Laish I, Katz H, Stein A, Liberman M, Naftali T, Kitay-Cohen Y, Biron-Shental T, Konikoff FM, Amiel A. Telomere dysfunction in peripheral blood lymphocytes from patients with primary sclerosing cholangitis and inflammatory bowel disease. Dig Liver Dis. 2015 Sep;47(9):790-6. doi: 10.1016/j.dld.2015.05.002. Epub 2015 May 13.
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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.
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 Primary Sclerosing Cholangitis and Inflammatory Bowel Disease, 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 2 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 25 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 (+972-549477261, ido.laish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length (time frame: 1.5 years). 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 NCT02247622, which also lists 1 linked publication.
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 25 Sep 2014.