Locoregionally-advanced Oropharyngeal Squamous Cell CarcinomaROMA LA-OPSCCNCT03759730
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma
An observational study of Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2018to 28 Nov 2018
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with locoregionally-advanced oropharyngeal squamous cell carcinoma
Who may be able to join
- Signed written and voluntary informed consent.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)
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.
Read the detailed description
To assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods: Saliva, Oropharyngeal swab over the tumor site (OP), Stool, and Rectal swab (optional).
This study is investigating the role of oral microbiota as a biomarker in LA-OPSCC. This is a minimal risk study involving the analysis of patient samples and does not involve therapeutic intervention. This protocol does not determine eligibility to receive treatment with concurrent radiotherapy and chemotherapy. It is anticipated that patient accrual will be completed within 12 months.
The study will involve a prospective cohort of up to 60 patients diagnosed with LA OPSCC treated with CRT at Princess Margaret Cancer Center.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
To assess the feasibility, the endpoint will be the proportion of analyzable samples.
Measured: 1 year
Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods
To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start5 Jan 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locoregionally-advanced Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Cancer CentreAnna Spreafico, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759730
- Sponsor's protocol ID
- ROMA LA-OPSCC-001
- Acronym
- ROMA LA-OPSCC
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2018
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No