Exploring biomarkers to improve treatment for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the role of tumor molecular profiles, UGT1A1 genotype, and intestinal microbiota enzyme activity in predicting treatment response and side effects for patients with metastatic or unresectable colorectal cancer undergoing irinotecan-based therapy. By identifying specific biomarkers, the study aims to personalize treatment, potentially enhancing efficacy and minimizing toxicity. The research focuses on understanding how these factors influence patient outcomes, including survival and quality of life, during systemic treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Maastricht UMC+
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Principal investigator: Marjolein Smidt, Prof. dr. — Maastricht University Medical Center
• Study coordinator: Janine Ziemons, M.Sc.
• Email: j.ziemons@maastrichtuniversity.nl
• Phone: +31 (0)433881558

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Biomarkers in Colorectal Cancer: A Longitudinal Study Using Biobanks and Blood Samples

  This study tests whether clinical and molecular biomarkers from tumor tissue and blood can predict treatment response, recurrence, and survival in adults with colorectal cancer undergoing surgery.

  Recruiting at 2 sites Vorarlberg Institute for Vascular Investigation and Treatment · Bregenz, Vorarlberg and 3 other locations · NCT07913802

• Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery

  Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.

  Recruiting Semmelweis University · Budapest · NCT07896174

• ctDNA blood test to spot buried cancer after surgery or treatment in colorectal cancer

  A blood test that looks for specific KRAS mutations in circulating tumor DNA to see if colorectal cancer has left residual disease or is likely to relapse.

  Recruiting Masaryk Memorial Cancer Institute · Brno, Czech Republic · NCT07895459

• Multimodal Survival Predictor for Colorectal Liver Metastases After Surgery

  Researchers are testing a tool that combines MRI-derived tumor features with clinical data to predict survival after surgery for colorectal liver metastases.

  Recruiting Anhui Provincial Hospital · Hefei, Anhui · NCT07830576

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

• AI-powered stool image analysis to see if it matches FIT results in colorectal cancer screening

  We’re testing whether AI-derived features from stool images can align with FIT results in adults being screened or evaluated for colorectal neoplasia.

  Recruiting Servicio de Salud Metropolitano Sur Oriente · Santiago, Santiago Metropolitan · NCT07740122

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.