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Study identifier: NCT05655780 Synced from ClinicalTrials.gov · July 28, 2026
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The Role of the Tumor Molecular Profile (CMS), UGT1A1 Genotype and Beta-glucuronidase Activity of the Intestinal Microbiota for Treatment Efficiency, Toxicity, Survival and Quality of Life in Patients With Metastatic or Unresectable Colorectal Cancer During Irinotecan-based Systemic Treatment

Condition: Colorectal Neoplasms  ·  Sponsor: Maastricht University Medical Center

PhaseN/A
Planned participants104
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Irinotecan-based systemic therapy is a treatment option for metastatic or unresectable colorectal cancer. However, this therapy has two major disadvantages, namely, an unpredictable response to the treatment and severe side effects, for instance diarrhea or a low white blood cell count (neutropenia). Therefore, the OPTIMA study was developed to find out if biomarkers, such as the molecular profile of the tumor, the UGT1A1 genotype and activity of the bacterial enzyme β-glucuronidase, can predict response and side effects during irinotecan treatment. By looking at these biomarkers, treatments could be more personalized, resulting into enhanced therapy efficiency, increased optimal survival and a better quality of life.

This description comes directly from the study's public registry record.

Talk to the study team

Janine Ziemons, M.Sc.  ·  +31 (0)433881558  ·  j.ziemons@maastrichtuniversity.nl

Always discuss trial participation with your own doctor first.

Locations (1)

Maastricht UMC+Maastricht, Limburg, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT05655780