Examining gut microbiome changes in advanced colorectal cancer during chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: J. J. de Haan, MD, PhD — University Medical Center Groningen
• Study coordinator: J. J. de Haan, MD, PhD
• Email: j.j.de.haan@umcg.nl
• Phone: +31 50 3612821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.