Gut microbiome dynamics in metastasized or irresectable colorectal cancer: initiating a prospective multicenter cohort

Gut microbiome dynamics in metastasized or irresectable colorectal cancer: initiating a prospective multicenter cohort - GIMICC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52467

Enrollment

300

Registered

2019-04-16

Start date

2020-09-09

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer colorectal cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Patients with histologically confirmed CRC with an indication for neo-adjuvant or palliative systemic anti-tumor therapy (ANY combination of chemotherapy with/without anti-VEGF of anti-EGFR therapy, or immunotherapy) - 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

Exclusion criteria: - Previous (neo)adjuvant chemotherapy

Design outcomes

Primary

Measure	Time frame
To predict which patients will develop a partial or complete response to systemic treatment based on the characteristics of the gut microbiome.	—

Secondary

Measure	Time frame
- To determine which bacteria in the pre-treatment gut microbiome predict serious side effects of conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer. - To determine the relation between alterations of the gut microbiome and bacterial metabolites during systemic anti-tumor therapy and efficacy and toxicity of systemic anti-tumor therapy.	—

Countries

Netherlands

Contacts

Public ContactJ.J. Haan

Universitair Medisch Centrum Groningen

j.j.de.haan@umcg.nl+31 50 3612821

Outcome results