Clinical trial · Observational
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)
NCT03759730CI-TRIAL-00036855ROMA LA-OPSCCcompletedClinicalTrials.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)
This is a minimal risk feasibility study involving the analysis of patient samples and does not involve any therapeutic intervention. The study will involve a prospective cohort of up to 60 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) treated with chemoradiotherapy (CRT) at Princess Margaret Cancer Centre.
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 |
|---|---|---|---|
| Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
- timeFrame
- 1 year
- description
- To assess the feasibility, the endpoint will be the proportion of analyzable samples.
- measure
- Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
- timeFrame
- 1 year
- description
- To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written and voluntary informed consent. 2. Patient must be willing and able to provide collection for saliva, OP swab and stool specimen analyses at 2 time points. Rectal swab is optional. 3. Age \> 18 years, male or female. 4. Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue). 5. Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy. Exclusion Criteria: \- 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.
References
Publications (0)
Data not yet available
No reference posted for this study.