NCT03759730

Completed

Role of Microbiome as a Biomarkers in Locoregionally-Advance...

University Health Network, Toronto Source

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Other study identifiers

Sponsor study identifier

ROMA LA-OPSCC-001

Study Type

observational

Actual enrollment (reported)

26

Locations

1 country

Sites

1

Timeline

Study Start

January 5, 2018

Actual (reported)

Primary Completion

November 28, 2018

Actual (reported)

Study Completion

November 28, 2018

Actual (reported)

Brief 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 (CRT) at Princess Margaret Cancer Centre.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 26 participants
Study completion date: November 28, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 5, 2018
Actual (reported)
First Submitted
November 23, 2018
Actual (reported)
Primary Completion
November 28, 2018
Actual (reported)
Study Completion
November 28, 2018
Actual (reported)
First Posted
November 30, 2018
Actual (reported)

Last Updated: October 1, 2026
Status Verified: September 2026
Last Update Submitted: September 30, 2026

Conditions

Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

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.
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.
1 year

Other Outcomes (1)

Evaluation of the relationship between oral and intestinal microbiome composition and diversity in LA-OPSCC patients undergoing CRT.
1 year

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects diagnosed with locoregionally-advanced oropharyngeal squamous cell carcinoma

You may qualify if:

Signed written and voluntary informed consent.

Sponsors & Collaborators

University Health Network, Toronto
Otherlead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, oropharyngeal swab over the tumor site, and stool sample are needed to assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing chemoradiotherapy (CRT).

Study Officials

Lillian Siu, MD
Princess Margaret Cancer Centre
PRINCIPAL INVESTIGATOR
Anna Spreafico, MD
Princess Margaret Cancer Centre
PRINCIPAL INVESTIGATOR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

November 30, 2018

Study Start

January 5, 2018

Actual (reported)

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.

You may not qualify if:

\- 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.

Contact the study team to confirm eligibility.

Primary Completion

November 28, 2018

Actual (reported)

Study Completion

November 28, 2018

Actual (reported)

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03759730
Data provider: ClinicalTrials.gov
Source updated: 2026-10-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:17 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Other Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations