Examining gut microbiome changes in advanced colorectal cancer during chemotherapy

Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)

This study looks at how chemotherapy changes the gut bacteria in people with advanced colorectal cancer to see if understanding these changes can help improve treatment outcomes.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Groningen (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 10 sites (Assen and 9 other locations)
• Trial ID: NCT03941080 on ClinicalTrials.gov

What this trial studies

This observational study investigates the characteristics and alterations of the gut microbiome in patients with metastasized or irresectable colorectal cancer undergoing chemotherapy. It aims to understand the relationship between gut microbiome dynamics and the effects of chemotherapy, which could lead to better predictive tools for treatment selection. By analyzing fecal and blood samples, along with patient questionnaires, the study seeks to identify factors that may enhance the efficacy of conventional chemotherapy. The findings could provide insights into how gut microbiome modulation might improve treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed metastatic or irresectable colorectal cancer who are eligible for palliative systemic anti-tumor therapy.

Not a fit: Patients who have undergone recent chemotherapy, radiotherapy, or surgery affecting the gastrointestinal tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with advanced colorectal cancer by tailoring therapies based on gut microbiome characteristics.

How similar studies have performed: While the relationship between gut microbiome and immunotherapy has been extensively studied, this specific focus on conventional chemotherapy is relatively novel and untested.

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

Where this trial is running

Assen and 9 other locations

• Wilhelmina Ziekenhuis — Assen, Netherlands (RECRUITING)
• Ziekenhuis Nij Smellinghe — Drachten, Netherlands (RECRUITING)
• Treant Zorggroep — Emmen, Netherlands (RECRUITING)
• Medisch Spectrum Twente — Enschede, Netherlands (RECRUITING)
• University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
• Martini Ziekenhuis — Groningen, Netherlands (RECRUITING)
• Tjongerschans Ziekenhuis — Heerenveen, Netherlands (RECRUITING)
• Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (RECRUITING)
• Ommelander Ziekenhuis Groep — Scheemda, Netherlands (RECRUITING)
• Antonius Zorggroep — Sneek, Netherlands (RECRUITING)

Study contacts

• Principal investigator: J. J. de Haan, MD, PhD — University Medical Center Groningen
• Study coordinator: J. J. de Haan, MD, PhD

Conditions: Colorectal Cancer Metastatic, colorectal cancer, gut microbiome