NCT05655780 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
| NCT ID | NCT05655780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Colorectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2023-01-09 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2023-01-09 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adult patient: 18 years of age or older * Patients diagnosed with metastatic or unresectable CRC, who will be treated with irinotecan-based systemic therapy with or without anti-eGFR treatment. * WHO performance status 0-2 * Minimal acceptable safety laboratory values defined as: * ANC of ≥ 1.5 x 109 /L * Platelet count of ≥ 100 x 109 /L * Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 2.5 x ULN; in case of liver metastases ALAT and ASAT ≤ 5 x ULN. * Renal function (eGFR) ≥ 50 ml/min or OR creatinine ≤ 1.5 x ULN * Written informed consent Exclusion Criteria: * Microsatellite instability (MSI) or deficient MMR proteins * Pregnant or nursing * Presence of ileostomy * Asian ethnicity * Other systemic treatment is less than one month before the start of the irinotecan-based treatment * Therapeutic antibiotic use is less than three months before the start of the irinotecan-based treatment * Abdominal radiotherapy is less than two weeks before the start of the irinotecan-based treatment * Physically or mentally incapable or incompetent * More than 25% irinotecan dose reduction at the start of treatment (dose reductions during treatment are allowed), with exception of dose reduction due to UGT1A1 mutation.
Contact & Investigator
Marjolein Smidt, Prof. dr.
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT05655780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05655780 currently recruiting?
Yes, NCT05655780 is actively recruiting participants. Contact the research team at j.ziemons@maastrichtuniversity.nl for enrollment information.
Where is the NCT05655780 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT05655780 clinical trial?
NCT05655780 is sponsored by Maastricht University Medical Center. The principal investigator is Marjolein Smidt, Prof. dr. at Maastricht University Medical Center. The trial plans to enroll 104 participants.