NCT03941080Recruiting
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)
Source: ClinicalTrials.gov · Last updated 1 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 29 Apr 2019
- Start date
- 9 Sept 2020
- Primary completion date
- Jan 2026
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Colorectal cancer
- NCT number
- NCT03941080
What you commit to
- Study type: Observational
- Planned participants: 300
- From 9 Sept 2020 to the primary completion date, Jan 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Uncontrolled inflammatory bowel disease
Other
- Participation in a study with a potential effect on the gut microbiome
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wilhelmina ziekenhuis Coordinator of this site? Confirm its status | Assen | Netherlands | Recruiting |
| Ziekenhuis Nij Smellinghe Coordinator of this site? Confirm its status | Drachten | Netherlands | Recruiting |
| Treant Zorggroep Coordinator of this site? Confirm its status | Emmen | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Martini Ziekenhuis Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Tjongerschans ziekenhuis Coordinator of this site? Confirm its status | Heerenveen | Netherlands | Recruiting |
| Medisch Centrum Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Ommelander Ziekenhuis Groep Coordinator of this site? Confirm its status | Scheemda | Netherlands | Recruiting |
| Antonius Zorggroep Coordinator of this site? Confirm its status | Sneek | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.