Actively Recruiting

Age: 18Years +
All Genders
ID03941080

Gut Microbiome Changes During Chemotherapy for Metastatic or Irresectable Colorectal Cancer A Prospective Multicenter Study by University Medical Center Groningen

Led by University Medical Center Groningen · Updated on 2025-01-01

300

Participants Needed

10

Research Sites

277 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the changes and characteristics of the gut microbiome during chemotherapy in patients with metastatic or irresectable colorectal cancer (CRC). The study aims to explore how the gut microbiome relates to the effects of chemotherapy, as current treatments have limited overall survival and significant side effects. Understanding the microbiome could help improve treatment selection and effectiveness for CRC patients undergoing systemic anti-tumor therapy. Participants will collect fecal samples at home before starting treatment and three months after treatment begins, coinciding with response evaluations. They will also fill out questionnaires about factors that might affect the microbiome, such as antibiotic or proton pump inhibitor use. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. Treatments include any combination of chemotherapy with or without anti-VEGF or anti-EGFR therapy. During the study, researchers will monitor changes in the gut microbiome and evaluate the patients' response to chemotherapy over two years. Outcome measures include prediction of response to conventional systemic anti-tumor therapy. Participants must provide informed consent and comply with study procedures, including sample collection and questionnaires. The study focuses on improving understanding of the microbiome's role in treatment outcomes and safety in metastatic or irresectable CRC.

CONDITIONS

Official Title

Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E�3D 18 years
  • Histologically confirmed colorectal cancer with indication for palliative systemic anti-tumor therapy
  • Measurable disease according to RECIST v1.1
  • Stored pathological specimens available
  • Life expectancy of at least 12 weeks
  • Signed informed consent form
  • Ability to comply with study protocol
Not Eligible

You will not qualify if you...

  • Previous (neo)adjuvant chemotherapy within the last 6 months
  • Previous radiotherapy on the small or large intestine within the last month
  • Previous surgery of the small or large intestine within the last month
  • Uncontrolled inflammatory bowel disease
  • Participation in a study that may affect the gut microbiome

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Wilhelmina Ziekenhuis

Assen, Netherlands

Actively Recruiting

2

Ziekenhuis Nij Smellinghe

Drachten, Netherlands

Actively Recruiting

3

Treant Zorggroep

Emmen, Netherlands

Actively Recruiting

4

Medisch Spectrum Twente

Enschede, Netherlands

Actively Recruiting

5

University Medical Center Groningen

Groningen, Netherlands, 9713 GZ

Actively Recruiting

6

Martini Ziekenhuis

Groningen, Netherlands

Actively Recruiting

7

Tjongerschans Ziekenhuis

Heerenveen, Netherlands

Actively Recruiting

8

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Actively Recruiting

9

Ommelander Ziekenhuis Groep

Scheemda, Netherlands

Actively Recruiting

10

Antonius Zorggroep

Sneek, Netherlands

Actively Recruiting

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Research Team

J

J. J. de Haan, MD, PhD

D

D. J. de Groot, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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