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Intestinal microbiota in colorectalcancer

Study protocol on the role of intestinal microbiota in colorectal cancer treatment: a pathway to personalized medicine 2.0.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29314
Enrollment
66
Registered
2018-01-17
Start date
2017-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal microbiota, microbiome, Colorectal cancer treatment, chemotoxicity, respons Intestinale microbiota, microbioom, colorectaal carcinoom behandeling, chemotoxiciteit, respons

Interventions

An explorative prospective multicenter cohort study in the Maastricht University Medical Centre+, Catharina Hospital and Zuyderland Medical Centre will be performed in 66 patients. Before, during, and

Sponsors

AZM
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients diagnosed with metastatic and/or irresectable CRC who will be treated with oral capecitabine (with or without intravenous bevacizumab) or oral trifluridine/tipiracil (TAS-102). • Aged 18 years or older. • Written informed consent.

Exclusion criteria

Exclusion criteria: • Proven Microsatellite instability (MSI). • Has not received any prior systemic therapy for the treatment of CRC during the previous 4 weeks prior to start of the current line of capecitabine or TAS-102. • Patients treated with additional systemic treatments during planned treatment period. • Radiotherapy within past 2 weeks prior to start. • Therapeutic antibiotic use within past 3 months prior to start. • Renal function: calculated creatinine clearance (Cockroft-Guilt) < 30 ml/min. •Pregnant or nursing. •Physically or mentally incapable or incompetent.

Design outcomes

Primary

MeasureTime frame
Microbiota composition before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 related to respons & chemotoxicity

Secondary

MeasureTime frame
Absolute microbiota abundance before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 related to respons & chemotoxicity

Contacts

Public ContactR Aarnoutse

Maastricht University Medical Center +, Department of Surgery

romy.aarnoutse@mumc.nl+31 (0)433-881558 / +316-82.01.91.05

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)