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Trial record 22 of 4147 for:    colon cancer AND Intestinal Neoplasms

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
Sponsor:
Information provided by (Responsible Party):
Dr. J.J. de Haan, 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.

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.


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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)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 :
  1. 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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Contacts
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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
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Netherlands
Wilhelmina Ziekenhuis Not yet recruiting
Assen, Netherlands
Contact: P. Nieboer, MD, PhD         
Ziekenhuis Nij Smellinghe Not yet recruiting
Drachten, Netherlands
Contact: G. Bouma, MD         
Treant Zorggroep Not yet 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 Not yet 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 Not yet 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 Not yet recruiting
Leeuwarden, Netherlands
Contact: B. Rikhof, MD, PhD         
Ommelander Ziekenhuis Groep Not yet recruiting
Scheemda, Netherlands
Contact: B. Poppema, MD         
Antonius Zorggroep Not yet recruiting
Sneek, Netherlands
Contact: G. Veldhuis, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: J. J. de Haan, MD, PhD University Medical Center Groningen

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Responsible Party: Dr. J.J. de Haan, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03941080     History of Changes
Other Study ID Numbers: 201900296
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. J.J. de Haan, University Medical Center Groningen:
colorectal cancer
gut microbiome

Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes