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.
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 Type
OBSERVATIONAL
Enrollment
300
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.
Wilhelmina Ziekenhuis
Assen, Netherlands
RECRUITINGZiekenhuis Nij Smellinghe
Drachten, Netherlands
RECRUITINGTreant Zorggroep
Emmen, Netherlands
Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
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
Time frame: 2 years
Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
To determine which bacteria strains in the microbiome predict serious side effects (grade 3/4 according to CTCAE v4.03) to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
Time frame: 2 years
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Medisch Spectrum Twente
Enschede, Netherlands
RECRUITINGUniversity Medical Center Groningen
Groningen, Netherlands
RECRUITINGMartini Ziekenhuis
Groningen, Netherlands
RECRUITINGTjongerschans Ziekenhuis
Heerenveen, Netherlands
RECRUITINGMedisch Centrum Leeuwarden
Leeuwarden, Netherlands
RECRUITINGOmmelander Ziekenhuis Groep
Scheemda, Netherlands
RECRUITINGAntonius Zorggroep
Sneek, Netherlands
RECRUITING