Clinical trial NCT03941080: Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Official title: Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer Metastatic
Keywords: colorectal cancer
gut microbiome
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present in the hospitals of the North Netherlands Colorectal Cancer Network. The participating hospitals together cover 10% of the Dutch population. Given that 13.000 patients yearly are diagnosed with colorectal cancer of which one third will develop metastatic or irresectable disease (www.iknl.nl), in the hospitals participating in this study 400 potential patients will present. Taking into account that about 50% do not fulfil in- and exclusion criteria or will refuse to participate, about 200 patients per year are expected to be included.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
timeFrame: 2 years
Secondary outcomes:
measure: Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
timeFrame: 2 years
Other outcomes:
Locations:
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis
city: Drachten
country: Netherlands
facility: Ziekenhuis Nij Smellinghe
city: Emmen
country: Netherlands
facility: Treant Zorggroep
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Heerenveen
country: Netherlands
facility: Tjongerschans Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Scheemda
country: Netherlands
facility: Ommelander Ziekenhuis Groep
city: Sneek
country: Netherlands
facility: Antonius Zorggroep
Study officials:
affiliation: University Medical Center Groningen
name: J. J. de Haan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: