Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Recruiting · NCT03941080 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →Interventions studied
Blood samplefecal samplequestionnaire
What this trial is about
In this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable CRC are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 18 years
- Patients with histologically confirmed CRC with an indication for palliative systemic anti-tumor therapy (ANY combination of chemotherapy with/without anti-VEGF of anti-EGFR therapy)
- Measurable disease according to RECIST v1.1.
- Stored pathological specimens available
- Life expectancy ≥ 12 weeks
- Signed Informed Consent Form
- Ability to comply with protocol
Exclusion criteria
- Previous (neo)adjuvant chemotherapy \< 6 months
- Previous radiotherapy on the small or large intestine \< 1month
- Previous surgery of the small or large intestine \< 1 month
- Uncontrolled inflammatory bowel disease
- Participation in a study with a potential effect on the gut microbiome
Where it is running
10 locations listed.
- Wilhelmina Ziekenhuis - Assen, Netherlands
- Ziekenhuis Nij Smellinghe - Drachten, Netherlands
- Treant Zorggroep - Emmen, Netherlands
- Medisch Spectrum Twente - Enschede, Netherlands
- University Medical Center Groningen - Groningen, Netherlands
- Martini Ziekenhuis - Groningen, Netherlands
- Tjongerschans Ziekenhuis - Heerenveen, Netherlands
- Medisch Centrum Leeuwarden - Leeuwarden, Netherlands
- Ommelander Ziekenhuis Groep - Scheemda, Netherlands
- Antonius Zorggroep - Sneek, Netherlands