Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

Overview

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.

Full Title of Study: “Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2022

Detailed Description

Although systemic treatment for metastasized or irresectable colorectal cancer (CRC) is becoming increasingly effective, overall survival is still poor and side effects of current treatment modalities are substantial. There is an urgent need for novel therapies, and in addition, better predictive tools are needed to select the right drug to the right patient. New data suggest that modulation of the microbiome of the gut might provide opportunities to increase anti-tumor efficacy of immunotherapy. Whereas the relation between the gut microbiome and immunotherapy is intensively studied, the relation between the gut microbiome and efficacy of conventional chemotherapy is unknown. A better understanding of the composition, function and dynamics of the gut microbiome before and during chemotherapy might help to identify factors that can be influenced during the treatment of patients with metastasized or irresectable CRC.

Therefore, 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.

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.

Arms, Groups and Cohorts

  • GIMICC
    • Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
    • Time Frame: 2 years
    • To determine which bacteria species in the microbiome predict response to conventional systemic anti-tumor therapy according to RECIST v1.1 for metastatic or irresectable colorectal cancer

Secondary Measures

  • Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
    • Time Frame: 2 years
    • To determine which bacteria strains in the microbiome predict serious side effects (grade 3/4 according to CTCAE v4.03) to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer

Participating in This Clinical Trial

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
  • Uncontrolled inflammatory bowel disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Groningen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. J.J. de Haan, Principal investigator – University Medical Center Groningen
  • Overall Official(s)
    • J. J. de Haan, MD, PhD, Principal Investigator, University Medical Center Groningen
  • Overall Contact(s)
    • J. J. de Haan, MD, PhD, +31 50 3612821, j.j.de.haan@umcg.nl

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