Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Diagnostic Test: fecal sample; Behavioral: questionnaire; Diagnostic Test: Blood sample

• Registration Number: NCT03941080
• Lead Sponsor: University Medical Center Groningen

Brief 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2020-09-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GIMICC	Blood sample	Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.
GIMICC	fecal sample	Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.
GIMICC	questionnaire	Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.

Primary Outcome Measures

Name	Time	Method
Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer	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 Outcome Measures

Name	Time	Method
Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer	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

Trial Locations

Locations (10)

Ommelander Ziekenhuis Groep; 🇳🇱 Scheemda, Netherlands

Ziekenhuis Nij Smellinghe; 🇳🇱 Drachten, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Wilhelmina Ziekenhuis; 🇳🇱 Assen, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Treant Zorggroep; 🇳🇱 Emmen, Netherlands

Tjongerschans Ziekenhuis; 🇳🇱 Heerenveen, Netherlands

Antonius Zorggroep; 🇳🇱 Sneek, Netherlands