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Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

NCT03941080 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-01-01

No results posted yet for this 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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DIAGNOSTIC_TEST

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.

BEHAVIORAL

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • J. J. de Haan, MD, PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941080 on ClinicalTrials.gov