Actively Recruiting
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
Eligibility Criteria
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
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
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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