SINGLE-CELL RNA SEQUENCING OF LYMPHOCYTE SUBSETS AND CHOLANGIOCYTES IN NON-ENDSTAGE PSC PATIENTS

Recruiting

• Conditions: Primairy sclerosing cholangitis; PSC; 10019654

• Registration Number: NL-OMON51642
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

Cases:
- established diagnosis of large duct PSC and concurrent inflammatory bowel
disease.
- Patients should be able to give written informed consent
- age >=18 year
- Child-Pugh-Turcott score <7
- Clinical indication for ERC, i.e. progressive complaints together with
increase in biochemical cholestasis or suspicion of malignancy.
- Thickened bile duct wall at the location of interest as evidenced by
dedicated ultrasound or MRC.

Controls:
- A suspected diagnosis of (peri)hilar cholangiocarcinoma
- Clinical indication for ERC, i.e. cholestatic itch, pre-operative drainage
- Patients should be able to give written informed consent
- Age >=18 year

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

Cases:
- signs of bacterial cholangitis
- mandatory anticoagulation

Controls:
- signs of bacterial cholangitis
- mandatory anticoagulation

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To characterize the disease specific composition and activity of immune cell<br /><br>subsets and cholangiocytes in active inflammation in the central/extrahepatic<br /><br>bile ducts of PSC patients and *normal* bileduct tissue using surface markers<br /><br>and in-depth transcriptomic analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To characterize immune cell subsets between peripheral blood of PSC patients<br /><br>and compare these to the bile duct derived subsets in relation to samples taken<br /><br>from *healthy* bileduct epithelium.<br /><br>2. To align the outcome of this transcriptomic analysis with known drug target<br /><br>genes.<br /><br>3. To align the outcome of this transcriptome analysis with previously<br /><br>identified inflammatory patterns in the colon of IBD patients with and without<br /><br>PSC<br /><br></p><br>