Prospective Sinonasal Cancer Multi-institution Study

August 1, 2023 updated by: Carlos D. Pinheiro Neto, Mayo Clinic

Sinonasal Cancer Study to Evaluate Oncologic Outcomes and Quality of Life

This is a multi-institution prospective study of patients with sinonasal malignancies. The goal of this study is to learn more about the course of sinonasal cancer, treatment outcomes, and patient quality of life. In addition, central mutational and genomic analysis of tumor tissue will be evaluated.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing treatment for sinonasal cancers

Description

Inclusion Criteria:

  • Subjects between the ages of 30 days (non-inclusive) and 99 years (inclusive)
  • Patients with a diagnosis of sinonasal cancer
  • Patients undergoing treatment at Mayo Clinic

Exclusion Criteria:

  • Healthy individuals
  • Unwilling to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oncologic outcomes as measured by overall survival, disease specific survival and recurrence free survival
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life outcomes including the University of Washington Quality of Life Questionnaire (UW-QOL v4) and the Sinonasal Outcome Test 22 (SNOT22)
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Describe the molecular foundation of sinonasal malignancies utilizing RNA sequencing to identify transcriptomic tumor profiles
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Carlos Pinheiro Neto, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20-010181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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