C80.9 R64
Conditions
Interventions
Group 1: Arm 1: Blood-, urine- and stool-samples of 60 patients with gastrointestinal tumors (UICC III-IV) without tumor cachexia will be frozen. The samples will be collected and send to the analysis
Sponsors
Asklepios Klinik Barmbek, Onkologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age > 18 years - Written informed consent - Histological confirmed gastrointestinal tumor (UICC stage III-IV) - No tumor cachexia ( 20 kg/m2) OR - Tumor cachexia present ( = 5% weight loss in =6 months of =2% weight loss if BMI < 20 kg/m2)
Exclusion criteria
Exclusion criteria: - Acute or sub-acute ileus - Known chronic-infectious gastrointestinal disease - Acute gastrointestinal infection - Therapy with antibiotics within = 2 weeks prior to study enrolment - Significant concomitant disease that would exclude the patient from participation, in the opinion of the investigator - Medical or mental impairment interfering with the ability to give informed consent - Limited or missing legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Evaluation of intestinal genes in stool samples of patients using next-generation sequencing technology - Identification of differences regarding the diversity of intestinal microorganisms between both groups Primary and endpoint will be assessed once based on the collected samples. No follow-up samples will be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assessment of typical metabolites of the anabolic and catabolic metabolism in blood and urine samples using mass spectroscopy-based technology - Identification of differences regarding metabolites of the anabolic and catabolic metabolism and/or metabolic profiles between both groups - Evaluation of an association between taxonomic composition of the gut microbiome, metabolic disorders and the presence of tumor cachexia - Identification of (possibly also rare) intestinal mircroorganisms, acting as driver, protector, and/or biomarker for metabolic disorders associated with tumor cachexia and/or changed metabolic processes. Primary secondary endpoint will be assessed once based on the collected samples. No follow-up samples will be collected. | — |
Countries
Germany
Contacts
Public ContactAxel Stang
Asklepios Klinik Barmbek, Onkologie
Outcome results
None listed