NCT04755855

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jan 2021Jan 2031

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

10 years

First QC Date

February 9, 2021

Last Update Submit

October 13, 2025

Conditions

Sinonasal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Oncologic outcomes as measured by overall survival, disease specific survival and recurrence free survival

    Through study completion, an average of 5 years

Secondary Outcomes (2)

  • Quality of life outcomes including the University of Washington Quality of Life Questionnaire (UW-QOL v4) and the Sinonasal Outcome Test 22 (SNOT22)

    Through study completion, an average of 5 years

  • Describe the molecular foundation of sinonasal malignancies utilizing RNA sequencing to identify transcriptomic tumor profiles

    Through study completion, an average of 5 years

Eligibility Criteria

Age30 Days - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing treatment for sinonasal cancers

You may qualify if:

  • 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

You may not qualify if:

  • Healthy individuals
  • Unwilling to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

  • Jake Eide, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashlee Kirtz

CONTACT

507-284-1231Kirtz.Ashlee@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 16, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Last Updated

October 15, 2025

Record last verified: 2025-10

Locations

US(1)