Preoperative treatment with metronidazole to evaluate its effectiveness in reducing tumor colonization by Fusobacterium nucleatum in patients with colorectal cancer
Zusammenfassung der Studie
• In the case of a diagnosis of colon cancer, a surgical procedure to remove the tumor is performed. • We often observe that patients have very different responses to cancer therapies. Our hypothesis is that the gut microbiota may play a role in modulating this response to cancer treatment, acting directly on tumor cells or on immune cells that are activated against the tumor. • To do this, we intend to analyze the gut flora and immune cells that were present at the site of your tumor both at the time of diagnosis and in the tumor tissue that will be removed during the surgical procedure, after treatment with the antibiotic metronidazole, to assess whether there are variations. The analyses will then be conducted on the already performed biopsies currently stored in the pathology archive, and on the piece of colon removed during the surgical procedure. • The main objective of our research project is to verify the effectiveness of the antibiotic metronidazole in reducing the concentration of a bacterium called Fusobacterium nucleatum in colorectal tumors.
(BASEC)
Untersuchte Intervention
Before the surgical procedure, where the tumor will be removed, he will need to take antibiotic tablets (metronidazole: an antibiotic approved in Switzerland and abroad) three times a day for 10 days.
(BASEC)
Untersuchte Krankheit(en)
Diagnosis of colon cancer
(BASEC)
- Written informed consent according to ICH-GCP prior to enrollment in the study - Age ≥ 18 years - Untreated primary colorectal adenocarcinoma (> 15 cm from the anal margin) - Colonoscopy with endoscopic biopsy for confirmation of disease and correlating studies. - Candidates for surgical resection prior to the administration of any therapy. (BASEC)
Ausschlusskriterien
- Insufficient biopsy tissue material to leave remnants in the pathology archives for further evaluations/analyses - Known history of hypersensitivity to metronidazole or other nitroimidazole derivatives - Oral or parenteral antibiotic therapy in the six weeks prior to enrollment - Emergency surgery (planned within less than 14 days), where there is no possibility of administering preoperative oral antibiotics - Other malignant diseases in the 5 years prior to enrollment in the study, except for basal cell or squamous skin cancer and cervical carcinoma in situ - Any previous antitumor treatment prior to resection - Pregnant or breastfeeding women - Women of childbearing potential or men who do not use safe contraception during the study period - Other clinically significant concomitant pathological states (e.g., renal failure, liver dysfunction, cardiovascular diseases, etc.) - Inability to consent to follow the study procedures, e.g., due to language problems, psychological disorders, dementia, etc. of the participant, - Participation in another study with an experimental drug in the 30 days prior to and during this study, - Any other serious medical, psychiatric, psychological, familial, or geographical condition that in the investigator's judgment may interfere with the planned staging, treatment, affect patient compliance, or put the patient at high risk of treatment-related complications. (BASEC)
Studienstandort
Bellinzona, Lugano
(BASEC)
Sponsor
Dr. med. Sara De Dosso
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Sara De Dosso
+41 91 811 9302
sara.dedosso@cluttereoc.chIstituto Oncologico della Svizzera Italiana Ente Ospedaliero Cantonale
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.10.2021
(BASEC)
ICTRP Studien-ID
NCT05748145 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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. (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
Metronidazole as Preoperative Therapy in CRC / FusoMetro-001 (ICTRP)
Untersuchte Krankheit(en)
Colorectal Cancer (ICTRP)
Untersuchte Intervention
Drug: Metronidazole Oral (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Impact of metronidazole on F.n. loads in CRC tissues. (ICTRP)
Potential effects of metronidazole on the expression of immune cell markers in CRC tissue samples;Potential effects of metronidazole on the expression of autophagy markers in CRC tissue samples;Potential effects of metronidazole on microbiome;Potential effects of metronidazole on the intestinal metabolic profile (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Sara De Dosso, MD;Sara De Dosso, MD, sara.dedosso@eoc.ch, +41 91 811 93 02;+41 91 811 93 02 (ICTRP)
Sekundäre IDs
FusoMetro-001 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05748145 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar