Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer (GIMICC)
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|ClinicalTrials.gov Identifier: NCT03941080|
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Metastatic||Diagnostic Test: fecal sample Behavioral: questionnaire Diagnostic Test: Blood sample|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.
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.
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.
- 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
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941080
|Contact: J. J. de Haan, MD, PhD||+31 50 firstname.lastname@example.org|
|Contact: D. J. de Groot, MD, PhD||+31 50 361 email@example.com|
|Wilhelmina Ziekenhuis||Not yet recruiting|
|Contact: P. Nieboer, MD, PhD|
|Ziekenhuis Nij Smellinghe||Not yet recruiting|
|Contact: G. Bouma, MD|
|Treant Zorggroep||Not yet recruiting|
|Contact: C. Oldenhuis, MD, PhD|
|Medisch Spectrum Twente||Not yet recruiting|
|Contact: L. Mekenkamp, MD, PhD|
|University Medical Center Groningen||Not yet recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: J. J. de Haan, MD, PhD +31 50 361 6161 firstname.lastname@example.org|
|Contact: D. J. de Groot, MD, PhD +31 50 361 2821 email@example.com|
|Principal Investigator: J. J. de Haan, PhD|
|Martini Ziekenhuis||Not yet recruiting|
|Contact: J. van Rooijen, MD|
|Saxenburgh Groep||Not yet recruiting|
|Contact: R. Blankenburgh, MD|
|Tjongerschans Ziekenhuis||Not yet recruiting|
|Contact: H. Bos, MD|
|Medisch Centrum Leeuwarden||Not yet recruiting|
|Contact: B. Rikhof, MD, PhD|
|Ommelander Ziekenhuis Groep||Not yet recruiting|
|Contact: B. Poppema, MD|
|Antonius Zorggroep||Not yet recruiting|
|Contact: G. Veldhuis, MD, PhD|
|Principal Investigator:||J. J. de Haan, MD, PhD||University Medical Center Groningen|