Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)
University Medical Center Groningen
300 participants
Sep 9, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria5
- 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
Interventions
patients will collect fecal samples at home prior to treatment and at 3 months after start of treatment at the time of response evaluation using a standard stool-collection-kit.
At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.
4 tubes of blood are collected prior to treatment and at 3 months after start of treatment at the time of response evaluation and sent to the UMCG for storage.
Locations(10)
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NCT03941080