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Swiss Primary Sclerosing Cholangitis Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146936
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione Epatocentro Ticino

Tracking Information
First Submitted Date May 8, 2017
First Posted Date May 10, 2017
Last Update Posted Date August 12, 2019
Actual Study Start Date February 28, 2017
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2019)
  • Disease course [ Time Frame: 3 years ]
    Observing disease course
  • Disease features [ Time Frame: 3 years ]
    Observing disease features in Swiss population and see if they are similar to other countries'
  • Response to treatment [ Time Frame: 3 years ]
    Observing response to treatment
  • Overall survival [ Time Frame: 3 years ]
    Observing overall survival
  • Transplantation-free survival rate [ Time Frame: 3 years ]
    Observing transplantation-free survival rate
Original Primary Outcome Measures
 (submitted: May 8, 2017)
  • Disease course [ Time Frame: 3 years ]
    Observing disease course
  • Disease features [ Time Frame: 3 years ]
    Observing disease features in Swiss population and see if they are similar to other countries'
  • Response to treatment [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]
  • Transplantation-free survival rate [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT03146936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Swiss Primary Sclerosing Cholangitis Cohort Study
Official Title Swiss Primary Sclerosing Cholangitis Cohort Study
Brief Summary

Research project in which biological material is sampled and health-related personal data is further used and collected.

Coded data are used.

Detailed Description The investigators wish to collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PSC. In addition, the cohort will allow collaborations with reference networks on PSC abroad
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
  1. Serum (BD Vacutainer® SST II Advance)
  2. RNA (PAXgene™ Blood RNA tube- 762165)
Sampling Method Non-Probability Sample
Study Population PSC patients living in Switzerland of any age Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases). Only patients living in Switzerland are enrolled. Enrollment of minors is possible upon consent of legal guardian
Condition Cholangitis, Sclerosing
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 8, 2017)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases) of any age. Patients not fulfilling such criteria but still diagnosed with PSC in a hepatology referral centre can be included
  • patients living in Switzerland

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Benedetta Terziroli Beretta-Piccoli, MD +41919608503 benedetta.terziroli@hin.ch
Contact: Benedetta Terziroli Beretta-Piccoli, MD Terziroli Beretta-Piccoli benedetta.terziroli@hin.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03146936
Other Study ID Numbers SASL40 - Swiss PSC Cohort
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fondazione Epatocentro Ticino
Study Sponsor Fondazione Epatocentro Ticino
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondazione Epatocentro Ticino
Verification Date August 2019