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出境医 / 临床实验 / Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer (GIMICC)
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer (GIMICC)
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer Metastatic | Diagnostic Test: fecal sample Behavioral: questionnaire Diagnostic Test: Blood sample |
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC) |
| Actual Study Start Date : | September 9, 2020 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
GIMICC
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.
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.
|
Outcome Measures
Primary Outcome 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 Outcome 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
Biospecimen Retention: Samples With DNA
Fecal sample and blood
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients who present in the hospitals of the North Netherlands Colorectal Cancer Network. The participating hospitals together cover 10% of the Dutch population. Given that 13.000 patients yearly are diagnosed with colorectal cancer of which one third will develop metastatic or irresectable disease (www.iknl.nl), in the hospitals participating in this study 400 potential patients will present. Taking into account that about 50% do not fulfil in- and exclusion criteria or will refuse to participate, about 200 patients per year are expected to be included.
Criteria
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
Contacts and Locations
Contacts
| Contact: J. J. de Haan, MD, PhD | +31 50 3612821 | j.j.de.haan@umcg.nl | |
| Contact: D. J. de Groot, MD, PhD | +31 50 361 2821 | d.j.a.de.groot@umcg.nl |
Locations
| Netherlands | |
| Wilhelmina Ziekenhuis | Recruiting |
| Assen, Netherlands | |
| Contact: P. Nieboer, MD, PhD | |
| Ziekenhuis Nij Smellinghe | Not yet recruiting |
| Drachten, Netherlands | |
| Contact: G. Bouma, MD | |
| Treant Zorggroep | Recruiting |
| Emmen, Netherlands | |
| Contact: C. Oldenhuis, MD, PhD | |
| Medisch Spectrum Twente | Not yet recruiting |
| Enschede, Netherlands | |
| Contact: L. Mekenkamp, MD, PhD | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9713 GZ | |
| Contact: J. J. de Haan, MD, PhD +31 50 361 6161 j.j.de.haan@umcg.nl | |
| Contact: D. J. de Groot, MD, PhD +31 50 361 2821 d.j.a.de.groot@umcg.nl | |
| Principal Investigator: J. J. de Haan, PhD | |
| Martini Ziekenhuis | Recruiting |
| Groningen, Netherlands | |
| Contact: J. van Rooijen, MD | |
| Saxenburgh Groep | Not yet recruiting |
| Hardenberg, Netherlands | |
| Contact: R. Blankenburgh, MD | |
| Tjongerschans Ziekenhuis | Not yet recruiting |
| Heerenveen, Netherlands | |
| Contact: H. Bos, MD | |
| Medisch Centrum Leeuwarden | Recruiting |
| Leeuwarden, Netherlands | |
| Contact: B. Rikhof, MD, PhD | |
| Ommelander Ziekenhuis Groep | Not yet recruiting |
| Scheemda, Netherlands | |
| Contact: B. Poppema, MD | |
| Antonius Zorggroep | Recruiting |
| Sneek, Netherlands | |
| Contact: G. Veldhuis, MD, PhD | |
Sponsors and Collaborators
University Medical Center Groningen
Investigators
| Principal Investigator: | J. J. de Haan, MD, PhD | University Medical Center Groningen |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 29, 2019 | ||||||||
| First Posted Date | May 7, 2019 | ||||||||
| Last Update Posted Date | October 22, 2020 | ||||||||
| Actual Study Start Date | September 9, 2020 | ||||||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome 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
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome 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
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer | ||||||||
| Official Title | Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC) | ||||||||
| 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. |
||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Fecal sample and blood
|
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients who present in the hospitals of the North Netherlands Colorectal Cancer Network. The participating hospitals together cover 10% of the Dutch population. Given that 13.000 patients yearly are diagnosed with colorectal cancer of which one third will develop metastatic or irresectable disease (www.iknl.nl), in the hospitals participating in this study 400 potential patients will present. Taking into account that about 50% do not fulfil in- and exclusion criteria or will refuse to participate, about 200 patients per year are expected to be included. | ||||||||
| Condition | Colorectal Cancer Metastatic | ||||||||
| Intervention |
|
||||||||
| Study Groups/Cohorts | GIMICC
Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.
Interventions:
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2022 | ||||||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | Netherlands | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03941080 | ||||||||
| Other Study ID Numbers | 201900296 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Dr. J.J. de Haan, University Medical Center Groningen | ||||||||
| Study Sponsor | University Medical Center Groningen | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | University Medical Center Groningen | ||||||||
| Verification Date | October 2020 | ||||||||
