Exploring the modulatory effects of gut microbiota on cholangiocarcinoma progression in a patient-derived organoid model

Recruiting

• Conditions: Cholangiocarcinoma; Intrahepatic bile duct carcinoma; C22.1

• Registration Number: DRKS00033188
• Lead Sponsor: nimedizin Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Histologically confirmed diagnosis of cholangiocarcinoma
No known liver-damaging diseases or other malignat diseases in medical history

Exclusion Criteria

Children and adolescents
Emergency surgery
Diagnosis of primary sclerosing cholangitis or other liver-damaging disease
Liver cirrhosis
Lack of compliance
Cognitive impairment (e.g. dementia)
Histologically confirmed diagnosis of another liver carcinoma
Diagnosis of gallbladder carcinoma

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cell viability of organoids after treatment with bacterial or fungal components compared to control organoids treated with solvent alone

Secondary Outcome Measures

Name	Time	Method
Stemness (the ability to renew and differentiate, e.g. via LGR5, CD44, EpCAM, NANOG and OCT4) as well as tumor-related markers (such as CK19, CK7, EpCAM, S100A6) of the treated organoids in comparison to the untreated control organoids. In addition, these markers will also be determined in the original tissue in order to evaluate differences between the organoids and the original tissue. <br>- Secondary socio-demographic and clinical target variables: <br>Age, underlying disease, origin, comorbidities, previous surgeries, long-term medication, diet, alcohol and nicotine consumption (current and history, extent of consumption), antibiotic therapy (current, as well as prior), previous therapies (radiation, chemotherapy), current weight, height, weight loss (yes vs. no), complications after surgery (based on Clavien-Dindo classification), laboratory chemistry parameters (CBC, electrolytes, CRP, tumor markers CEA and CA 19.9, recurrence and distant metastasis rate and death in the 1st and 2nd year of treatment