Clinical trial · Observational
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)
NCT03941080CI-TRIAL-00084274GIMICCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
| fecal sample | Diagnostic Test | — | UNRESOLVED |
| questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GIMICC
- description
- Adult patients with newly diagnosed metastasized or irresectable CRC with an indication for standard palliative systemic anti-tumor treatment.
- interventionNames
- Diagnostic Test: fecal sample
- Behavioral: questionnaire
- Diagnostic Test: Blood sample
Primary outcomes (1)
- measure
- Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
- timeFrame
- 2 years
- description
- 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 outcomes (1)
- measure
- Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.