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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033188

Enrollment

Registered

2024-01-30

Start date

2024-02-22

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma C22.1

Interventions

Group 1: Both male and female adult patients suffering from cholangiocarcinoma and undergoing elective resection are eligible for inclusion in the study. All types of CCA will be considered, regardles

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
"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. - Secondary socio-demographic and clinical target variables: 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	—

Measure

Time frame

"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. - Secondary socio-demographic and clinical target variables: 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

—

Countries

Germany

Contacts

Public ContactAnn-Kathrin Lederer

Unimedizin Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

ann-kathrin.lederer@unimedizin-mainz.de+496131177291

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026