Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 10
- Primary Endpoint
- Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
Overview
Brief 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.
Detailed Description
Although systemic treatment for metastasized or irresectable colorectal cancer (CRC) is becoming increasingly effective, overall survival is still poor and side effects of current treatment modalities are substantial. There is an urgent need for novel therapies, and in addition, better predictive tools are needed to select the right drug to the right patient. New data suggest that modulation of the microbiome of the gut might provide opportunities to increase anti-tumor efficacy of immunotherapy. Whereas the relation between the gut microbiome and immunotherapy is intensively studied, the relation between the gut microbiome and efficacy of conventional chemotherapy is unknown. A better understanding of the composition, function and dynamics of the gut microbiome before and during chemotherapy might help to identify factors that can be influenced during the treatment of patients with metastasized or irresectable CRC.
Therefore, 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Outcomes
Primary Outcomes
Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
Time Frame: 2 years
To determine which bacteria species in the microbiome predict response to conventional systemic anti-tumor therapy according to RECIST v1.1 for metastatic or irresectable colorectal cancer
Secondary Outcomes
- Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer(2 years)