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Clinical Trials in the Netherlands / NCT03941080
Recruiting Observational

Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

NCT03941080 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University Medical Center Groningen
Phase
Observational
Started
2020-09-09
Last updated
2025-01-01

Condition(s) studied

Colorectal Cancer Metastatic

Investigational drug(s) / intervention(s)

fecal samplequestionnaireBlood sample

fecal sample: patients will collect fecal samples at home prior to treatment and at 3 months after start of treatment at the time of response evaluation using a standard stool-collection-kit.

questionnaire: At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.

Blood sample: 4 tubes of blood are collected prior to treatment and at 3 months after start of treatment at the time of response evaluation and sent to the UMCG for storage.

Study summary

In this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable CRC are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
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
Tjongerschans Ziekenhuis Heerenveen Netherlands Recruiting
Medisch Centrum Leeuwarden Leeuwarden Netherlands Recruiting
Ommelander Ziekenhuis Groep Scheemda Netherlands Recruiting
Antonius Zorggroep Sneek Netherlands Recruiting

More University Medical Center Groningen trials in the Netherlands

PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action Recruiting
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease Recruiting
Investigating Cardiovascular Adverse Events Related to Cancer Treatment Active, not recruiting
Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression Recruiting
Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection Recruiting

Other trials for the same condition

Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy Starting soon
Galunisertib Combined With Capecitabine in Advanced CRC With PM Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03941080 on ClinicalTrials.gov ↗ ← All trials in the Netherlands