Status:
ACTIVE_NOT_RECRUITING
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
NuBiyota
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-centre feasibility study designed to assess the safety, tolerability and engraftment of MET-4 bacterial strains when given in combination with chemoradiotherapy (CRT). The study will ...
Detailed Description
Past findings suggest oral microbiome might be used to predict recurrence and response to therapies, as past studies have shown surgery, radiotherapy and chemotherapy alter the microbiome, which in tu...
Eligibility Criteria
Inclusion
- Signed written and voluntary informed consent.
- Patient must be willing and able to provide:
- Oropharyngeal swab, stool and blood specimen at protocol specified time points.
- Age \> 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue).
- Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy.
Exclusion
- Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
- Subjects unable to swallow orally administered medications or any subjects with gastrointestinal disorders likely to interfere with absorption (e.g. bowel obstruction, short gut syndrome, blind loop syndrome, ileostomy etc). Subjects with colostomies may be enrolled.
- Pregnant or planning to get pregnant in the next 6 months.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03838601
Start Date
July 2 2019
End Date
March 1 2026
Last Update
March 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9