D12.6
Conditions
Interventions
Group 1: Children and young adults, diagnosed with familial adenomatous polyposis undergoing routine endoscopy.
Sponsors
Universitätsklinikum Heidelberg, Klinik Kinderheilkunde I
Eligibility
Sex/Gender
All
Age
No minimum to 20 Years
Inclusion criteria
Inclusion criteria: Patients (<20years) with a genetically confirmed diagnosis of familial adenomatous polyposis coli in the premalignant stage who receive an endoscopic examination of the lower (or upper) gastrointestinal tract as part of routine care. In case of inclusion of a pediatric patient, inclusion of the patient mother of a pediatric patient included in the study. Written informed consent of the legal representative, as well as (if age-related reasonably possible) of the patient.
Exclusion criteria
Exclusion criteria: Refusal of consent Presence of an infectious disease Impossibility of obtaining biomaterial during endoscopy (e.g., discontinuation of the examination for non-study-related reasons)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of DNA of colibactin-forming bacteria in polyp material, association with the presence of early somatic mutations using organoid lines from patient material. | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of additional genotoxic bacteria and association with the presence of early somatic mutations. Generation of organoids from patient materials. Correlation of DNA genotoxic in stool of patient mothers with presence in children. | — |
Countries
Germany
Outcome results
None listed