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

Recruiting

Conditions: colorectal cancer
10017991

Registration Number: NL-OMON52467

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

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

- Previous (neo)adjuvant chemotherapy < 6 months
- Previous radiotherapy on the small or large intestine < 1 month
- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To predict which patients will develop a partial or complete response to<br /><br>systemic treatment based on the characteristics of the gut microbiome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine which bacteria in the pre-treatment gut microbiome predict<br /><br>serious side effects of conventional systemic anti-tumor therapy for metastatic<br /><br>or irresectable colorectal cancer.<br /><br>- To determine the relation between alterations of the gut microbiome and<br /><br>bacterial metabolites during systemic anti-tumor therapy and efficacy and<br /><br>toxicity of systemic anti-tumor therapy.</p><br>