Clinical trial · Interventional
Metronidazole as Preoperative Therapy in CRC / FusoMetro-001
Preoperative Treatment With Metronidazole to Evaluate the Efficacy in Reducing Fusobacterium Nucleatum Tumor Colonization in Patients With Colorectal Cancer (CRC): a Proof-of-concept Trial
NCT05748145CI-TRIAL-00097432recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fusobacterium nucleatum load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metronidazole Oral | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metronidazole treated arm
- description
- Administration of Metronidazole for 10 days prior to surgery in CRC patients
- interventionNames
- Drug: Metronidazole Oral
Primary outcomes (1)
- measure
- Impact of metronidazole on F.n. loads in CRC tissues.
- timeFrame
- 12 (+ 3) days after surgery
- description
- F.n. load assessed by qRT-PCR analysis in excised tumor tissues upon antibiotic treatment, as compared to corresponding diagnostic biopsies prior to treatment.
Secondary outcomes (4)
- measure
- Potential effects of metronidazole on the expression of immune cell markers in CRC tissue samples
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent according to ICH/GCP regulations before registration. * Age ≥ 18 years old * Untreated, primary colorectal adenocarcinoma (\> 15 cm from the anal verge) * Colonoscopy with endoscopic biopsy for disease confirmation and correlative studies. * Candidates for surgical resection prior to administration of any therapy. Exclusion Criteria: * Insufficient material on the tissue biopsy to be left in the archives of the Cantonal Institute of Pathology for further evaluations/analyses * Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives * Oral or parenteral antibiotic therapy within the six weeks prior to enrolment * Emergency surgery (planned within less than 14 days), where no opportunity to administer preoperative oral antibiotics exists * Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervices uteri * Any previous anticancer treatment prior resection * Women who are pregnant or breast feeding * Fertile women or men who do not use safe contraception during the study period * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.), * Inability to consent and follow the procedures of the study e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment, affect patient compliance or place the patient at high risk from treatment-related complications
References
Publications (0)
Data not yet available
No reference posted for this study.