C18 C19 C20
Conditions
Interventions
Group 1: Surgical patients undergoing surgery for colorectal cancer: immunophenotyping by PBMCs and metagenomic analyses from stool, mucosa, and saliva samples perioperatively and during oncologic fol
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients Patients capable of giving informed consent Presence of a valid declaration of informed consent Presence of a valid declaration of informed consent for participation in biobanking Patients with colorectal carcinoma or screening colonoscopy (control group)
Exclusion criteria
Exclusion criteria: age younger than 18 years no informed consent for participation of biobanking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the differential abundance of the colonic mucosa of patients with CRC vs. healthy controls for evaluation as diagnostic biomarkers based on metagenomic analyzes (microbial pattern) | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of the microbial niches "tumor" and "colonic mucosa" of a retrospective cohort from the biobank i.A. HTCR using metagenomic and metabolomic markers Characterization of the microbial niches "tumor", "colonic mucosa", "stool" and "saliva" of a prospective cohort of patients with CRC using metagenomic and metabolomic markers as well as immunophenotyping from peripheral blood/tissue. Evaluation of metabolomic, metagenomic patterns and immunophenotypes as biomarkers for the diagnosis of CRC from tumor tissue, healthy mucosa, stool and saliva samples Development of a predictive model for prediction of tumor stage and oncological prognosis (survival) based on metabolomic and metagenomic patterns from mucosa and tumor tissue using a retrospective cohort with tissue from the biobank i.A. HTCR. Evaluation of the diagnostic performance of the predictive model using a prospective cohort of patients with CRC. Correlation of metabolome and metagenome of different microbial niches with each other: mucosa, tumor, saliva, stool Correlation of metabolomic, metagenomic patterns from the different tissues/samples and immunophenotypes with o UICC tumor stages (I-IV) o Tumor grading (G1-G3) o tumor location (right vs. left hemicolon, rectum) o perioperative outcome o oncological prognosis: disease-free/overall survival o stage III/IV therapy regimens o molecular tumor status, expression of transcription factors Correlation of perioperative and oncologic outcome with clinical data. | — |
Countries
Germany
Contacts
Public ContactKoordinationszentrum Chirurgische Studien
Klinikum der Universität München
Outcome results
None listed