Colorectal Cancer Metastatic Clinical Trial
— GIMICCOfficial title:
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)
NCT number | NCT03941080 |
Other study ID # | 201900296 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 9, 2020 |
Est. completion date | January 2024 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wilhelmina Ziekenhuis | Assen | |
Netherlands | Ziekenhuis Nij Smellinghe | Drachten | |
Netherlands | Treant Zorggroep | Emmen | |
Netherlands | Medisch Spectrum Twente | Enschede | |
Netherlands | Martini Ziekenhuis | Groningen | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Tjongerschans Ziekenhuis | Heerenveen | |
Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
Netherlands | Ommelander Ziekenhuis Groep | Scheemda | |
Netherlands | Antonius Zorggroep | Sneek |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer | 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 | 2 years | |
Secondary | Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer | 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 | 2 years |
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