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

Summary

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.

Conditions

• Colorectal Neoplasms

Sponsors & Collaborators

• Maastricht University

  collaborator OTHER

• Wageningen University & Research

  collaborator UNKNOWN

• Fontys Hogeschool

  collaborator UNKNOWN

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Catharina Ziekenhuis

  collaborator UNKNOWN

• University of North Carolina (USA)

  collaborator UNKNOWN

• Oncology patientenpanel MUMC

  collaborator UNKNOWN

• Stichting Kanker.nl

  collaborator UNKNOWN

• Van Weel-Bethesda Ziekenhuis

  collaborator UNKNOWN

• VieCuri Medisch Centrum voor Noord-Limburg

  collaborator UNKNOWN

• Gelderse Vallei Hospital

  collaborator OTHER

• Danone Nutricia Research

  collaborator INDUSTRY

• Clinical Trial Center Maastricht B.V.

  collaborator OTHER

• Dutch Colorectal Cancer Group (DCCG)

  collaborator UNKNOWN

• Prospectief Landelijk CRC Cohort (PLCRC)

  collaborator UNKNOWN

• CRC-guideline committee

  collaborator UNKNOWN

• CZ zorgverzekeraar

  collaborator UNKNOWN

• Landelijke Werkgroep Diëtisten Oncologie (LWDO)

  collaborator UNKNOWN

• Rode Kruis Ziekenhuis Beverwijk

  collaborator UNKNOWN

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Marjolein Smidt, Prof. dr. · Maastricht University Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-09

Primary Completion

2025-10-31

Completion

2028-12-31

Countries

• Netherlands

Study Locations